Product Code: MQV FDA class 2 21 CFR 888.3045

Filler, Bone Void, Calcium Compound

Orthopedic

The Calcium Compound Bone Void Filler is an orthopedic implant made from calcium-based materials (such as calcium sulfate, calcium phosphate, or hydroxyapatite) used to fill bony defects and voids, supporting bone healing and regeneration. Classified as FDA Class 2 under 21 CFR 888.3045 in the Orthopedic specialty, it requires 510(k) premarket notification. The product code is MQV, and it carries an implant flag.

View on FDA

510(k)s

492

FEI Numbers

229

Registration Numbers

229

Unique Applicants

183

Years Active

Basic Information

Product Code: MQV
Device Class: FDA class 2
Regulation Number: 888.3045
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 492 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260364	Device 300419 Strip	Jun 02, 2026	Substantially Equivalent	Geistlich Pharma AG
K252797	JAZBI Resorbable Bone Void Filler	May 26, 2026	Substantially Equivalent	Sdip Innovations Pty, Ltd.
K261008	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute	Apr 24, 2026	Substantially Equivalent	Stryker Spine
K253524	Adaptos®Fuse Bone Graft	Feb 17, 2026	Substantially Equivalent	Biomendex OY
K253147	FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute	Oct 22, 2025	Substantially Equivalent	Prosidyan, Inc.
K251522	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE	Oct 13, 2025	Substantially Equivalent	Bone Solutions, Inc.
K252085	Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)	Sep 30, 2025	Substantially Equivalent	Wright Medical Technology, Inc. (Stryker Corporation)
K251556	Device 300423 Granules	Jul 17, 2025	Substantially Equivalent	Geistlich Pharma AG
K251720	OsteoFlo HydroFiber	Jul 02, 2025	Substantially Equivalent	SurGenTec, LLC
K251193	Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft	Jun 12, 2025	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K243949	OsteoFlo HydroFiber	May 28, 2025	Substantially Equivalent	SurGenTec, LLC
K243474	MagnetOs MIS	May 23, 2025	Substantially Equivalent	Kuros Biosciences B.V
K250141	Synthecure Synthetic Calcium Sulfate	May 16, 2025	Substantially Equivalent	Austin Medical Ventures, Inc.
K250521	NanoBone® SBX Putty ; NanoBone® QD	Apr 07, 2025	Substantially Equivalent	Biocomposites, Ltd.
K250556	Porous Biologic Scaffold	Mar 21, 2025	Substantially Equivalent	Ventris Medical
K250346	BonVie+	Feb 26, 2025	Substantially Equivalent	Elute, Inc.
K241555	Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	Feb 21, 2025	Substantially Equivalent	Rti Surgical, Inc.
K243706	Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules	Jan 17, 2025	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K242797	OsteoFlo HydroFiber	Dec 23, 2024	Substantially Equivalent	SurGenTec, LLC
K242782	GlassBone Granules	Dec 23, 2024	Substantially Equivalent	Noraker
K241167	BioSphere Putty; BioSphere MIS Putty	Dec 20, 2024	Substantially Equivalent	Synergy Biomedical
K243609	EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )	Dec 18, 2024	Substantially Equivalent	Etex Corporation
K240765	Porous Biologic Scaffold	Dec 18, 2024	Substantially Equivalent	Ventris Medical
K243526	MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty	Dec 05, 2024	Substantially Equivalent	Orthocon, Inc.
K243506	Montage-XT Settable Bone Putty	Nov 18, 2024	Substantially Equivalent	Orthocon, Inc.
K241802	Device 300397 Putty	Nov 08, 2024	Substantially Equivalent	Geistlich Pharma AG
K240450	Citrepore	Nov 06, 2024	Substantially Equivalent	Acuitive Technologies, Inc.
K242372	Mg OSTEOREVIVE, Mg OSTEOCRETE	Oct 18, 2024	Substantially Equivalent	Bone Solutions, Inc.
K242299	NovaBone Putty - Synthetic Bioactive Bone Graft	Sep 25, 2024	Substantially Equivalent	Novabone Products, LLC
K242273	Cove Putty, OsteoCove Putty	Sep 25, 2024	Substantially Equivalent	SeaSpine Orthopedics Corporation
K242280	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips	Aug 29, 2024	Substantially Equivalent	Stryker Spine
K233566	Montage-XT Settable, Resorbable Bone Putty	Aug 21, 2024	Substantially Equivalent	Orthocon, Inc.
K241564	Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS	Aug 02, 2024	Substantially Equivalent	Baxter Healthcare Corporation
K242050	Montage Settable Bone Putty	Jul 29, 2024	Substantially Equivalent	Orthocon, Inc.
K241212	MagnetOs Easypack Putty	Jun 27, 2024	Substantially Equivalent	Kuros Biosciences
K233259	Xerosyn	Jun 21, 2024	Substantially Equivalent	Xerothera, Inc.
K240621	Morpheus® Moldable; Agilon® Moldable	Apr 30, 2024	Substantially Equivalent	Biogennix, LLC
K240442	MagnetOs Putty	Apr 01, 2024	Substantially Equivalent	Kuros Biosciences B.V
K240507	NuVasive AttraX Scaffold	Mar 20, 2024	Substantially Equivalent	Nuvasive, Inc.
K240424	Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix	Mar 12, 2024	Substantially Equivalent	Collagen Matrix, Inc.
K240458	Synthetic Bone Putty	Mar 07, 2024	Substantially Equivalent	Ventris Medical
K240459	Cerament Bone Void Filler	Mar 05, 2024	Substantially Equivalent	Bonesupport AB
K240404	NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)	Mar 05, 2024	Substantially Equivalent	Novabone Products, LLC
K240453	ReBOSSIS	Mar 04, 2024	Substantially Equivalent	Orthorebirth Co., Ltd.
K234013	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE	Feb 05, 2024	Substantially Equivalent	Bone Solutions, Inc.
K232347	MagnetOs Granules	Jan 19, 2024	Substantially Equivalent	Kuros Biosciences B.V
K231968	Tactoset® Injectable Bone Substitute	Dec 20, 2023	Substantially Equivalent	Anika Therapeutics, Inc.
K230736	MagnetOs Putty	Dec 20, 2023	Substantially Equivalent	Kuros Biosciences B.V
K233607	MagnetOs Easypack Putty	Dec 15, 2023	Substantially Equivalent	Kuros Biosciences B.V
K233490	SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty	Dec 05, 2023	Substantially Equivalent	Bioventus, LLC
K233245	MagnetOs Flex Matrix	Nov 21, 2023	Substantially Equivalent	Kuros Biosciences B.V
K231716	OsteoFlo® HydroPutty	Oct 02, 2023	Substantially Equivalent	SurGenTec, LLC
K232668	Cove Strip, OsteoCove Strip	Sep 27, 2023	Substantially Equivalent	SeaSpine Orthopedics Corporation
K232315	Catalyst Bone Void Filler	Sep 15, 2023	Substantially Equivalent	Ossdsign AB
K231030	Cove Putty, OsteoCove Putty	Sep 14, 2023	Substantially Equivalent	SeaSpine Orthopedics Corporation
K231270	Montage Flowable Settable, Resorbable Bone Paste	Sep 01, 2023	Substantially Equivalent	Orthocon, Inc.
K231903	Montage-QS Settable, Resorbable Bone Putty	Aug 25, 2023	Substantially Equivalent	Orthocon, Inc.
K230486	Cove Strip	Aug 21, 2023	Substantially Equivalent	SeaSpine Orthopedics Corporation
K231942	Mineral Collagen Composite Bioactive Extra Moldable	Aug 02, 2023	Substantially Equivalent	Collagen Matrix, Inc.
K231714	Graftys Quickset	Jul 12, 2023	Substantially Equivalent	Graftys
K231528	Bonalive Orthopedics granules	Jul 11, 2023	Substantially Equivalent	Bonalive Biomaterials, Ltd.
K223915	Tactoset	Mar 29, 2023	Substantially Equivalent	Anika Therapeutics, Inc.
K230054	DSM Biomedical Calcium Phosphate Cement	Mar 21, 2023	Substantially Equivalent	Dsm Biomedical
K222063	MONTAGE Settable, Resorbable Bone Putty	Feb 03, 2023	Substantially Equivalent	Orthocon, Inc.
K220337	GaiaBone Bioabsorbable Bone Graft	Feb 03, 2023	Substantially Equivalent	Corliber (Shenzhen) Medical Device Co., Ltd.
K223563	OsteoCNX	Jan 25, 2023	Substantially Equivalent	Converg Engineering
K221726	Uni-FuZe-C Bone Strip	Jan 18, 2023	Substantially Equivalent	Zavation Medical Products, LLC
K221735	Mineral Collagen Composite Bioactive Moldable	Dec 20, 2022	Substantially Equivalent	Collagen Matrix, Inc.
K221644	Synthetic Bone Putty	Sep 02, 2022	Substantially Equivalent	Ventris Medical
K213803	FIBERGRAFT Aeridyan Matrix Bone Graft Substitute	Aug 23, 2022	Substantially Equivalent	Prosidyan, Inc.
K221256	Mg OSTEOINJECT	Jun 28, 2022	Substantially Equivalent	Bone Solutions, Inc.
K213959	MagnetOs Flex Matrix	Apr 14, 2022	Substantially Equivalent	Kuros Biosciences B.V
K212721	Genex Bone Graft Substitute	Feb 04, 2022	Substantially Equivalent	Biocomposites, Ltd.
K212991	Osteorevive	Jan 21, 2022	Substantially Equivalent	Bone Solutions, Inc.
K213111	MagnetOs granules	Jan 10, 2022	Substantially Equivalent	Kuros Biosciences B.V
K213342	PRO-DENSE LoVisc Bone Graft Substitute	Jan 05, 2022	Substantially Equivalent	Wrightmedicaltechnologyinc
K212156	ABCcolla Bone Matrix	Oct 08, 2021	Substantially Equivalent	Acro Biomedical Co., Ltd.
K212135	Dry DBM- A Putty	Oct 04, 2021	Substantially Equivalent	Seaspine Corporation
K212353	DB-EZ Bone Void Filler	Sep 22, 2021	Substantially Equivalent	Dimensional Bioceramics, LLC
K211201	MagnetOs Easypack Putty	Sep 02, 2021	Substantially Equivalent	Kuros Biosciences B.V
K212083	Tactoset Injectable Bone Substitute	Aug 31, 2021	Substantially Equivalent	Anika Therapeutics, Inc.
K203218	CaP Spheres Pellet Pack	May 04, 2021	Substantially Equivalent	Zimmer Biomet Spine, Inc.
K202639	si-Mochi	Apr 21, 2021	Substantially Equivalent	Biostone, Ltd.
K210193	DB-Composite	Mar 15, 2021	Substantially Equivalent	Dimensional Bioceramics, LLC
K201781	Uni-FuZe-P Bone Putty	Dec 28, 2020	Substantially Equivalent	Zavation Medical Products, LLC
K200507	PRO-DENSE LoVisc Bone Graft Substitute	Oct 21, 2020	Substantially Equivalent	Wrightmedicaltechnologyinc
K201535	Cerament Bone Void Filler	Oct 16, 2020	Substantially Equivalent	Bonesupport AB
K200064	OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft	Aug 14, 2020	Substantially Equivalent	SurGenTec, LLC
K191670	CureOs TCP	Aug 04, 2020	Substantially Equivalent	Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
K201464	Altapore MIS	Jun 30, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K193513	SIGNAFUSE Bioactive Bone Graft	Jun 18, 2020	Substantially Equivalent	Bioventus
K193075	Osteo3 ZP Putty	Jun 09, 2020	Substantially Equivalent	Sirakoss , Ltd.
K200290	Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)	May 11, 2020	Substantially Equivalent	SeaSpine Orthopedics Corporation
K200640	ALTAPORE SHAPE	May 08, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K200752	DB-Orthopedics	Apr 22, 2020	Substantially Equivalent	Dimensional Bioceramics, LLC
K193487	Agilon Strip	Mar 30, 2020	Substantially Equivalent	Biogennix, LLC
K193168	Agilon Moldable	Feb 13, 2020	Substantially Equivalent	Biogennix, LLC
K190956	SCS 17-01	Jan 30, 2020	Substantially Equivalent	Anika Therapeutics, Inc.
K192363	Altapore	Jan 09, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K193040	Resorbable Mesh Device	Nov 30, 2019	Substantially Equivalent	SeaSpine Orthopedics Corporation
K191974	NuVasive AttraX Putty	Nov 03, 2019	Substantially Equivalent	Nu Vasive, Incorporated
K191513	Altapore Shape	Oct 19, 2019	Substantially Equivalent	Baxter Healthcare Corporation
K191074	Sorrento Bone Graft Substitute	Sep 27, 2019	Substantially Equivalent	Xenco Medical, LLC
K190371	Morpheus-C	Aug 09, 2019	Substantially Equivalent	Biogennix, LLC
K191274	BonAlive Granules	Aug 07, 2019	Substantially Equivalent	Bonalive Biomaterials, Ltd.
K191764	Inion BioRestore	Jul 31, 2019	Substantially Equivalent	Inion OY
K190754	Orthoss(R)	Jun 23, 2019	Substantially Equivalent	Geistlich Pharma AG
K190814	AccuFill Bone Substitute Material	Jun 10, 2019	Substantially Equivalent	Zimmer Knee Creations
K190482	IGNITE Bone Void Filler	May 28, 2019	Substantially Equivalent	Wrightmedicaltechnologyinc
K190110	NanoBone SBX PUTTY, NanoBone QD	Apr 23, 2019	Substantially Equivalent	Artoss GmbH
K182074	Mineral Collagen Composite Bioactive Moldable	Mar 21, 2019	Substantially Equivalent	Collagen Matrix, Inc.
K190283	PROSTIM Injectable Inductive Graft	Mar 14, 2019	Substantially Equivalent	Wrightmedicaltechnologyinc
K182670	FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute	Dec 20, 2018	Substantially Equivalent	Prosidyan, Inc.
K181958	MagnetOs Putty	Dec 06, 2018	Substantially Equivalent	Kuros Biosciences B.V
K182823	PRODENSE Bone Graft Substitute	Nov 02, 2018	Substantially Equivalent	Wrightmedicaltechnologyinc
K180758	Osteocera Resorbable Bone Substitute	Oct 24, 2018	Substantially Equivalent	Wiltrom Corporation Limited
K181721	Ceracell Ortho Foam	Sep 17, 2018	Substantially Equivalent	Curasan AG
K173933	Sorrento Bioglass Bone Graft Substitute	Sep 13, 2018	Substantially Equivalent	Xenco Medical, LLC
K181255	PRODENSE Bone Graft Substitute	Sep 12, 2018	Substantially Equivalent	Wrightmedicaltechnologyinc
K173424	BioSphere Flex	Sep 12, 2018	Substantially Equivalent	Synergy Biomedical
K182107	CarriGen PF	Aug 31, 2018	Substantially Equivalent	Etex Corporation
K181225	ALTAPORE	Aug 31, 2018	Substantially Equivalent	Baxter Healthcare Corporation
K181306	Actifuse Flow	Aug 17, 2018	Substantially Equivalent	Baxter Healthcare Corporation
K180853	EP Granules BVF	Aug 06, 2018	Substantially Equivalent	Elute, Inc.
K181585	JGH1 Core Deccompression Procedure Kit	Jul 20, 2018	Substantially Equivalent	AgNovos Healthcare USA, LLC
K181342	JGH1 Bone Graft Substitute	Jul 19, 2018	Substantially Equivalent	AgNovos Healthcare USA, LLC
K173572	DSM Biomedical Calcium Phosphate Cement with Microspheres	May 09, 2018	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical
K180121	Rafugen DBM	Apr 11, 2018	Substantially Equivalent	Cellumed Co., Ltd.
K180080	FIBERGRAFT BG Matrix Bone Graft Substitute	Apr 06, 2018	Substantially Equivalent	Prosidyan, Inc.
K173525	NovoGro	Apr 06, 2018	Substantially Equivalent	Osteonovus, Inc.
K173362	DSM Biomedical Calcium Phosphate Cement	Apr 03, 2018	Substantially Equivalent	Kensey Nash Corporation Dba Dsm Biomedical
K171568	SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty	Feb 22, 2018	Substantially Equivalent	Hans Biomed Corporation
K172237	Bicera Resorbable Bone Substitute	Feb 02, 2018	Substantially Equivalent	Wiltrom Corporation Limited
K171629	ABCcolla Bone Graft	Feb 01, 2018	Substantially Equivalent	Acro Biomedical Co., Ltd.
K173301	BioSphere MIS Putty (BioSphere MIS)	Jan 19, 2018	Substantially Equivalent	Synergy Biomedical, LLC
K170165	Osteo-P Bone Graft Substitute	Dec 29, 2017	Substantially Equivalent	Molecular Matrix, Inc.
K173008	SCS 17-01	Dec 26, 2017	Substantially Equivalent	Anika Therapeutics, Inc.
K172573	ReBOSSIS85	Dec 15, 2017	Substantially Equivalent	Orthorebirth Co., Ltd.
K172497	NuVasive AttraX Scaffold	Nov 24, 2017	Substantially Equivalent	Nu Vasive, Incorporated
K172130	Resorbable Mesh Device	Nov 16, 2017	Substantially Equivalent	SeaSpine Orthopedics Corporation
K170917	Bi-Ostetic Bioactive Glass Foam	Oct 30, 2017	Substantially Equivalent	Berkeley Advanced Biomaterials
K171161	Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)	Sep 25, 2017	Substantially Equivalent	Dimensional Bioceramics, LLC
K171563	MagnetOs Putty	Aug 24, 2017	Substantially Equivalent	Kuros Biosciences B.V
K171284	FIBERGRAFT BG Matrix Bone Graft Substitute	Jun 30, 2017	Substantially Equivalent	Prosidyan, Inc.
K170620	ReBOSSIS85	Jun 23, 2017	Substantially Equivalent	Orthorebirth Co., Ltd.
K170306	FIBERGRAFT BG Putty Bone Graft Substitute	May 24, 2017	Substantially Equivalent	Prosidyan, Inc.
K163621	Vitoss Bioactive (BA) Injectable	May 02, 2017	Substantially Equivalent	Orthovita, Inc.
K162087	NovoGro	Apr 18, 2017	Substantially Equivalent	Osteonovus, Inc.
K161859	MagnetOs	Feb 24, 2017	Substantially Equivalent	Xpand Biotechnology BV
K161996	0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE	Feb 16, 2017	Substantially Equivalent	Amend Surgical, Inc.
K162860	MCS Bone Graft	Feb 13, 2017	Substantially Equivalent	Bioventus, LLC
K163310	NovaBone IRM	Jan 18, 2017	Substantially Equivalent	Novabone Products, LLC
K160566	Cerasorb Ortho Foam	Dec 02, 2016	Substantially Equivalent	Curasan AG
K160446	MCP Bone Putty	Nov 07, 2016	Substantially Equivalent	Biostructures, LLC
K161351	NanoBone SBX Putty	Oct 26, 2016	Substantially Equivalent	Artoss GmbH
K161447	HydroSet XT	Oct 06, 2016	Substantially Equivalent	Orthovita, Inc.
K152077	MaxiGen	Apr 21, 2016	Substantially Equivalent	Hans Biomed Corp.
K151271	BellaFuse	Mar 11, 2016	Substantially Equivalent	Hans Biomed Corp.
K153608	Vitoss BiModal Bone Graft Substitute Foam Strip	Feb 12, 2016	Substantially Equivalent	Orthovita, Inc.
K152589	Bio2 CLM BG Bioactive Scaffold	Jan 12, 2016	Substantially Equivalent	Bio2 Technologies, Inc.
K151154	FIBERGRAFT BG Morsels	Nov 10, 2015	Substantially Equivalent	Prosidyan, Inc.
K151584	AttraX Putty	Oct 08, 2015	Substantially Equivalent	Progentix Orthobiology BV
K150064	Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)	Sep 04, 2015	Substantially Equivalent	Orthogem, Ltd.
K152071	NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)	Aug 26, 2015	Substantially Equivalent	Novabone Products, LLC
K143692	GranOSTM - beta tricalcium phosphate synthetic bone granules	Aug 21, 2015	Substantially Equivalent	Tcm Associates, Ltd.
K150621	OsteoSelect PLUS Demineralized Bone Matrix Putty	Aug 18, 2015	Substantially Equivalent	Bacterin International, Inc.
K151172	MASTERGRAFT Contain	Aug 14, 2015	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K141725	BONGOLD BONE GRAFT MATERIAL	Jul 09, 2015	Substantially Equivalent	Beijing Allgens Medical Science & Technology Co, L
K143533	FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE	Mar 25, 2015	Substantially Equivalent	Prosidyan, Inc.
K141429	SORRENTO BONE GRAFT SUBSTITUTE	Feb 23, 2015	Substantially Equivalent	Haider Biologics, LLC
K132868	CARRICELL	Feb 20, 2015	Substantially Equivalent	Etex Corporation
K140913	NUROS BONE GRAFT SUBSTITUTE	Feb 17, 2015	Substantially Equivalent	Oriental Resources Development Limited
K141189	NANOBONE / GRANULATE	Jan 30, 2015	Substantially Equivalent	Artoss GmbH
K141830	STIMULAN KIT, STIMULAN RAPID CURE	Jan 23, 2015	Substantially Equivalent	Biocomposites, Ltd.
K142104	NANOFUSE DBM	Jan 21, 2015	Substantially Equivalent	Nanotherapeutics, Inc.
K142276	MCS Bone Graft	Jan 16, 2015	Substantially Equivalent	Biostructures, LLC
K142828	osteoSPAN Morpheus	Jan 15, 2015	Substantially Equivalent	Biogennix
K143549	Vivorte Trabexus	Jan 14, 2015	Substantially Equivalent	Vivorte, Inc.
K142463	Bio2 CLM BG Bioactive Scaffold	Dec 18, 2014	Substantially Equivalent	Bio2 Technologies, Inc.
K141207	NOVABONE BIOACTIVE STRIP	Oct 31, 2014	Substantially Equivalent	Novabone Products, LLC
K142090	REBOSSIS	Oct 29, 2014	Substantially Equivalent	Orthorebirth Co., Ltd.
K141600	NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT	Oct 17, 2014	Substantially Equivalent	Pioneer Surgical Technology, Inc. (Rti Surgical, I
K141824	MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP	Sep 05, 2014	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K133678	CONFIRM BIOACTIVE	Aug 26, 2014	Substantially Equivalent	Globus Medical, Inc.
K140946	NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE	Aug 22, 2014	Substantially Equivalent	Novabone Products, LLC
K141956	FIBERGRAFT BG MORSELS	Aug 13, 2014	Substantially Equivalent	Prosidyan, Inc.
K141746	AS20 COMPOSITE GRAFT	Aug 04, 2014	Substantially Equivalent	Wrightmedicaltechnologyinc
K132211	SKAFFOLD NMX BONE VOID FILLER	Aug 04, 2014	Substantially Equivalent	Skeletal Kinetics, LLC
K141841	INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP	Aug 01, 2014	Substantially Equivalent	Integra Lifescience Corportation
K140844	BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC	Jul 16, 2014	Substantially Equivalent	Synergy Biomedical, Inc.
K132470	SOLUM IV BONE VOID FILLER	May 21, 2014	Substantially Equivalent	Spinesmith Partners, Llp
K132377	OSTEOSPAN MORPHEUS	May 20, 2014	Substantially Equivalent	Biogennix, LLC
K140375	MASTERGRAFT PUTTY, MASTERGRAFT STRIP	Apr 18, 2014	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K130531	ULTRAFUSE	Apr 08, 2014	Substantially Equivalent	Baxter Healthcare Corp
K132656	PRODENSE BONE GRAFT SUBSTITUTE	Mar 24, 2014	Substantially Equivalent	Wrightmedicaltechnologyinc
K132805	BG MORSELS	Mar 14, 2014	Substantially Equivalent	Prosidyan, Inc.
K132050	NB3D BONE VOID FILLER	Feb 07, 2014	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K132071	BIOACTIVE BONE GRAFT PUTTY	Jan 10, 2014	Substantially Equivalent	Biostructures, LLC
K130977	SIGNIFY BIOACTIVE	Dec 24, 2013	Substantially Equivalent	Globus Medical, Inc.
K131673	MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT	Oct 03, 2013	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K130392	KINEX BIOACTIVE	Aug 15, 2013	Substantially Equivalent	Globus Medical, Inc.
K131133	VIVORTE BVF LITE	Aug 12, 2013	Substantially Equivalent	Vivorte, Inc.
K130953	NEOTIS; NEOTIS 50	Jul 15, 2013	Substantially Equivalent	Sbm Sciences For Bio Materials
K130335	MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX	Apr 19, 2013	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K122868	BIOSPHERE BIOACTIVE BONE GRAFT PUTTY	Apr 19, 2013	Substantially Equivalent	Synergy Biomedical, LLC
K113871	PRO-DENSE BONE GRAFT SUBSTITUTE	Mar 25, 2013	Substantially Equivalent	Wrightmedicaltechnologyinc
K120354	BETA-TCP GRANULES	Mar 21, 2013	Substantially Equivalent	Skeletal Kinetics, LLC
K121453	A-GRIX TE RESORABLE BONE VOID FILLER	Feb 05, 2013	Substantially Equivalent	Ag Digital Technology Corp.
K123691	MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)	Jan 31, 2013	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K121313	MTF NEW BONE VOID FILLER	Jan 11, 2013	Substantially Equivalent	Musculoskeletal Transplant Foundation
K121989	OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,	Nov 27, 2012	Substantially Equivalent	Exactech, Inc.
K110949	BICERA (TM) RESORBABLE BONE SUBSTITUTE	Sep 18, 2012	Substantially Equivalent	Wiltrom Corporation Limited
K120141	KENSEY NASH BONE VOID FILLER XC	May 04, 2012	Unknown	Kensey Nash Cororation
K120279	NANOFUSE DBM	Apr 06, 2012	Substantially Equivalent	Nanotherapeutics
K120602	APACERAM BONE GRAFT SUBSTITUTE	Mar 23, 2012	Substantially Equivalent	Hoya Corporation
K113791	B-GENIN, R-GENIN	Mar 15, 2012	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K111018	POLYFUSE - NEUROBONE	Feb 14, 2012	Substantially Equivalent	Atpac Medical, LLC
K112383	CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER	Feb 07, 2012	Substantially Equivalent	Skeletal Kinetics, LLC
K113167	MTF NEW BONE VOILD FILLER	Jan 24, 2012	Substantially Equivalent	Musculoskeletal Transplant Foundation
K112857	INTERFACE BONE VOID FILLER	Dec 13, 2011	Substantially Equivalent	Biostructures, LLC
K111944	NB3D BONE VOID FILLER	Nov 22, 2011	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K112773	NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT	Oct 14, 2011	Substantially Equivalent	Novabone Products, LLC
K110003	MTF NEW BONE VOID FILLER	Oct 13, 2011	Substantially Equivalent	Musculoskeletal Transplant Foundation
K111838	INQU PASTE MIX	Sep 26, 2011	Substantially Equivalent	Isto Technologies, Inc.
K103799	INQU PASTE MIX PLUS	Aug 29, 2011	Substantially Equivalent	Isto Technologies, Inc.
K110925	NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT	Jul 05, 2011	Substantially Equivalent	Novabone Products, LLC
K110976	ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM	May 03, 2011	Substantially Equivalent	Nanotherapeutics, Inc.
K110561	FORTROSS BONE VOID FILLER	Apr 29, 2011	Substantially Equivalent	Pioneer Surgical Technology
K110787	TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)	Apr 21, 2011	Substantially Equivalent	Orthogem Limited
K110368	NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT	Apr 14, 2011	Substantially Equivalent	Novabone Products, LLC
K103795	DBX DEMINERALIZED BONE MATRIX PUTTY	Apr 13, 2011	Substantially Equivalent	Musculoskeletal Transplant Foundation
K103784	DBX DEMINERALIZED BONE MATRIX PUTTY	Apr 13, 2011	Substantially Equivalent	Musculoskeletal Transplant Foundation
K103173	VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE	Feb 07, 2011	Substantially Equivalent	Orthovita, Inc.
K102722	NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY	Jan 27, 2011	Substantially Equivalent	Synthes USA Products, LLC
K103036	ALLOFUSE PLUS	Jan 10, 2011	Substantially Equivalent	Allosource, Inc.
K102937	OSTEOPHIL BETA-TCP	Dec 27, 2010	Substantially Equivalent	Cytophil, Inc.
K102392	MICROFUSE PUTTY AND MICROFUSE ST MIS	Dec 22, 2010	Substantially Equivalent	Globus Medical, Inc.
K092541	INTERFACE	Nov 09, 2010	Substantially Equivalent	Biostructures
K102545	FM-02 BONE GRAFT SUBSTITUTE	Oct 27, 2010	Substantially Equivalent	Orthovita, Inc.
K101860	NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT	Sep 01, 2010	Substantially Equivalent	Novabone Products, LLC
K100841	BONEOPTIMIZER	Aug 19, 2010	Substantially Equivalent	Curasan AG
K093342	BIOGENNIX RPC	Jul 29, 2010	Substantially Equivalent	Biogennix, LLC
K100986	CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION	Jul 20, 2010	Substantially Equivalent	Skeletal Kinetics, LLC
K101557	GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN	Jul 01, 2010	Substantially Equivalent	Etex Corp.
K091912	B-GENIN AND R-GENIN	Jun 23, 2010	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K092608	SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX	May 28, 2010	Substantially Equivalent	Collagen Matrix, Inc.
K100361	NANOSS BONE VOID FILLER	Apr 22, 2010	Substantially Equivalent	Pioneer Surgical Technology
K093343	GRAFTY QUICKSET	Apr 22, 2010	Substantially Equivalent	Graftys
K092046	BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY	Mar 24, 2010	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K091688	A-GRIX RESORBABLE BONE VOID FILLER	Mar 02, 2010	Substantially Equivalent	Ag Digital Technology Corp.
K093447	CARRIGEN	Feb 18, 2010	Substantially Equivalent	Etex Corp.
K090401	ORTHOSS	Jan 08, 2010	Substantially Equivalent	Ed. Geistlich Soehne AG Fur Chemische Industrie
K091302	INTEGRA MOZAIK AND OS MOLDABLE MORSELS	Dec 04, 2009	Substantially Equivalent	Integra LifeSciences Corporation
K073214	DUOWEDGE SYNTHETIC BONE SUBSTITUTE	Dec 01, 2009	Substantially Equivalent	Kasios
K091031	PIONEER SURGICAL NANOSS BVF-E	Nov 17, 2009	Substantially Equivalent	Pioneer Surgical Technology
K091607	ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE	Nov 02, 2009	Substantially Equivalent	Etex Corp.
K090641	CURIOS	Oct 23, 2009	Substantially Equivalent	Progentix Orthobiology BV
K091218	DBX DEMINERALIZED BONE MATRIX PUTTY	Sep 28, 2009	Substantially Equivalent	Musculoskeletal Transplant Foundation
K090387	KAINOS+	Sep 28, 2009	Substantially Equivalent	Signus Medizintechnik GmbH
K090855	EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE	Sep 18, 2009	Substantially Equivalent	Etex Corp.
K091321	OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY	Sep 11, 2009	Substantially Equivalent	Bacterin International, Inc.
K090871	CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12	Sep 04, 2009	Substantially Equivalent	Bonesupport AB
K083270	WMT COMPOSITE DBM	Aug 27, 2009	Substantially Equivalent	Wrightmedicaltechnologyinc
K083449	E-MATRIX GRAFT BONE EXTENDER	Jun 12, 2009	Substantially Equivalent	Pioneer Surgical Technology
K082166	MASTERGRAFT STRIP	Jun 02, 2009	Substantially Equivalent	Medtronic Sofamor Danek
K082419	REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1	May 27, 2009	Substantially Equivalent	Intra-Lock International, Inc.
K071004	OSTEOCRETE BONE VOID FILLER	May 21, 2009	Substantially Equivalent	Bone Solutions, Inc.
K090731	NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD	Apr 15, 2009	Substantially Equivalent	Novabone Products, LLC
K082793	INTERGRO DBM	Apr 02, 2009	Substantially Equivalent	Biomet Spine
K090310	EQUIVABONE	Mar 24, 2009	Substantially Equivalent	Etex Corp.
K082498	GRAFTYS HBS	Feb 25, 2009	Substantially Equivalent	Graftys
K090242	GAMMA-BSM, BETA-BSM	Feb 20, 2009	Substantially Equivalent	Etex Corp.
K090177	INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE	Feb 20, 2009	Substantially Equivalent	Inion OY
K082918	MASTERGRAFT RESORBABLE CERAMIC GRANULES	Feb 09, 2009	Substantially Equivalent	Medtronic Sofamor Danek
K083279	CALTRIX RESORBABLE BONE VOID FILLER	Jan 28, 2009	Substantially Equivalent	Ag Digital Technology Corp.
K083232	MODIFICATION TO:MICROFUSE BONE VOID FILLER	Dec 24, 2008	Substantially Equivalent	Globus Medical, Inc.
K082672	NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT	Dec 09, 2008	Substantially Equivalent	Novabone Products, LLC
K071849	ALLOFUSE GEL AND PUTTY	Dec 04, 2008	Substantially Equivalent	Allosource, Inc.
K082575	ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES	Nov 25, 2008	Substantially Equivalent	Apatech , Ltd.
K082002	PROGENIX PLUS	Nov 24, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K082381	GENEX	Nov 14, 2008	Substantially Equivalent	Biocomposites, Ltd.
K083033	VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE	Nov 06, 2008	Substantially Equivalent	Orthovita, Inc.
K081979	ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE	Nov 06, 2008	Substantially Equivalent	Apatech , Ltd.
K082615	GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES	Oct 16, 2008	Substantially Equivalent	Osteotech, Inc.
K082338	POLYBONE GRANULE & BLOCK	Oct 16, 2008	Substantially Equivalent	Kyung Won Medical Co., Ltd.
K081717	TRICOS A RESORBABLE BONE SUBSTITUTE	Oct 10, 2008	Substantially Equivalent	Baxter Healthcare Corp
K082442	MODIFICATION TO MICROFUSE BONE VOID FILLER	Oct 07, 2008	Substantially Equivalent	Globus Medical, Inc.
K082073	ACTIFUSE FLOW BONE GRAFT SUBSTITUTE	Sep 11, 2008	Substantially Equivalent	Apatech , Ltd.
K081758	HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015	Sep 03, 2008	Substantially Equivalent	Depuy Spine, Inc.
K081558	PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC	Aug 25, 2008	Substantially Equivalent	Pioneer Surgical Technology
K081227	PLEXUR M	Jul 22, 2008	Substantially Equivalent	Osteotech, Inc.
K073341	GENEX PUTTY	Jul 09, 2008	Substantially Equivalent	Biocomposites, Ltd.
K073316	CERAMENT BONE VOID FILLER, MODEL A0210	Jun 20, 2008	Substantially Equivalent	Bonesupport AB
K081439	VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE	Jun 17, 2008	Substantially Equivalent	Orthovita, Inc.
K080009	NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT	May 06, 2008	Substantially Equivalent	Novabone Products, LLC
K080065	OSFERION	May 02, 2008	Substantially Equivalent	Olympus Terumo Biomaterials Corporation
K080511	PLEXUR-P	Apr 21, 2008	Substantially Equivalent	Osteotech, Inc.
K080736	ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE	Apr 16, 2008	Substantially Equivalent	Apatech , Ltd.
K062691	COMPORUS	Apr 15, 2008	Substantially Equivalent	Takiron Co., Ltd.
K072444	WELLGRAFT PE I	Apr 04, 2008	Substantially Equivalent	Gwowei Technology Co., Ltd.
K072170	WELLGRAFT PE II	Apr 04, 2008	Substantially Equivalent	Gwowei Technology Co., Ltd.
K073064	GRAFTYS BCP	Mar 11, 2008	Substantially Equivalent	Graftys
K063157	MERRIES K-PHATE BONE GRAFT SUBSTITUTE	Mar 10, 2008	Substantially Equivalent	Merries International, Inc.
K073405	PLEXUR M	Mar 03, 2008	Substantially Equivalent	Osteotech, Inc.
K071199	BONALIVE GRANULES	Feb 01, 2008	Substantially Equivalent	Vivoxid , Ltd.
K072238	BIOSET XCH	Jan 25, 2008	Substantially Equivalent	Regeneration Technologies, Inc.
K072265	PROGENIX DMB PUTTY	Jan 09, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K071187	MICROFUSE BONE VOID FILLER	Dec 20, 2007	Substantially Equivalent	Globus Medical, Inc.
K071876	CROSS.BONE	Dec 17, 2007	Substantially Equivalent	TriMed, Inc.
K063050	CAP PLUS	Nov 19, 2007	Substantially Equivalent	Etex Corp.
K071813	MASTERGRAFT PUTTY	Nov 09, 2007	Substantially Equivalent	Medtronic Sofamor Danek
K062607	POLYGRAFT BGS	Nov 09, 2007	Unknown	Smith & Nephew, Inc.
K071912	APACERAM BONE GRAFT SUBSTITUTE	Oct 29, 2007	Substantially Equivalent	Pentax Corp.
K072327	CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON	Oct 24, 2007	Substantially Equivalent	Regeneration Technologies, Inc.
K072636	A-BSM BONE SUBSTITUTE MATERIAL	Oct 23, 2007	Substantially Equivalent	Etex Corp.
K071046	SYNTHES CHRONOS COMPOSITE	Oct 23, 2007	Substantially Equivalent	Synthes (Usa)
K072597	PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT	Oct 15, 2007	Substantially Equivalent	Wrightmedicaltechnologyinc
K070751	ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY	Oct 15, 2007	Substantially Equivalent	Isotis Orthobiologics, Inc.
K070998	INION BIORESTORE	Oct 11, 2007	Substantially Equivalent	Inion OY
K072355	OSSIFUSE BONE SUBSTITUTE MATERIAL	Sep 26, 2007	Substantially Equivalent	Etex Corp.
K072384	MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE	Sep 21, 2007	Substantially Equivalent	Kensey Nash Corp.
K072184	VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE	Sep 18, 2007	Substantially Equivalent	Orthovita, Inc.
K071428	INQU	Sep 17, 2007	Substantially Equivalent	Isto Technologies, Inc.
K070897	BONEMEDIK, AND BONEMEDIK-S	Sep 17, 2007	Substantially Equivalent	Meta Biomed Co., Ltd.
K071121	TRIBONE 80	Sep 11, 2007	Substantially Equivalent	Biomatlante
K061880	ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC	Aug 15, 2007	Substantially Equivalent	Isotis NV
K063527	MBCP+	Jul 30, 2007	Substantially Equivalent	Biomatlante
K070132	TRIPORE, MODELS HA, BP90, BP15	Jul 13, 2007	Substantially Equivalent	Orthogem Limited
K070794	ATLANTIK	Jul 10, 2007	Substantially Equivalent	Medical Biomat
K071155	MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER	Jul 03, 2007	Substantially Equivalent	Science For Biomaterials
K062630	OSSIPRO BONE SUBSTITUTE MATERIAL	Jun 28, 2007	Substantially Equivalent	Etex Corp.
K071237	COPIOS BONE VOID FILLER SPONGE AND PASTE	Jun 01, 2007	Substantially Equivalent	Kensey Nash Corp.
K070864	BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER	Jun 01, 2007	Substantially Equivalent	Biomet Osteobiologics
K071206	ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE	May 31, 2007	Substantially Equivalent	Apatech , Ltd.
K070437	PRO-DENSE BONE VOID FILLER	May 09, 2007	Substantially Equivalent	Wrightmedicaltechnologyinc
K063346	PRO OSTEON 500R	Apr 18, 2007	Substantially Equivalent	Ebi, L.P.
K063359	INQU	Apr 16, 2007	Substantially Equivalent	Isto Technologies, Inc.
K070220	OSTEOFIX BONE VOID FILLER	Apr 12, 2007	Substantially Equivalent	Calcitec, Inc.
K062459	ORIGEN DBM WITH BIOACTIVE GLASS	Feb 26, 2007	Substantially Equivalent	Nanotherapeutics
K062200	COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS	Feb 13, 2007	Substantially Equivalent	Collagen Matrix, Inc.
K061499	OSFERION	Jan 26, 2007	Substantially Equivalent	Olympus America, Inc.
K063124	INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS	Jan 19, 2007	Substantially Equivalent	Integra Lifesciences Corp.
K053218	DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX	Dec 28, 2006	Substantially Equivalent	Musculoskeletal Transplant Foundation
K062353	MOZAIK BONE REGENERATION MATRIX - PUTTY	Dec 20, 2006	Substantially Equivalent	Integra LifeSciences Corporation
K061462	BF+ (PH)	Dec 15, 2006	Substantially Equivalent	Ldr Spine USA
K062496	OSTEOPORE TCP	Oct 19, 2006	Substantially Equivalent	Spinecraft, Inc.
K062495	HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM	Oct 13, 2006	Substantially Equivalent	Depuy Spine, Inc.
K061311	ALLOGRAN-R	Sep 22, 2006	Substantially Equivalent	Biocomposites, Ltd.
K060917	KENSEY NASH BONE VOID FILLER	Sep 22, 2006	Substantially Equivalent	Kensey Nash Corporation
K061939	MODIFICATION TO ALLOMATRIX CUSTOM	Jul 18, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K053213	BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM	Jul 06, 2006	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K060809	OSTEO-LINK BONE VOID FILLER PELLETS	Jul 03, 2006	Substantially Equivalent	Promed Advance Technology Co., Ltd.
K061022	BIO 1-KIT BIOSORB FILLED CARTRIDGE	May 24, 2006	Substantially Equivalent	Science For Biomaterials
K060728	NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT	May 01, 2006	Substantially Equivalent	Novabone Products, LLC
K060432	NOVABONE POROUS-BONE GRAFT SCAFFOLD	Apr 04, 2006	Substantially Equivalent	Novabone Products, LLC
K060408	NORIAN SRS BONE VOID FILLER	Mar 21, 2006	Substantially Equivalent	Synthes (Usa)
K060406	NORIAN SRS FAST SET PUTTY	Mar 20, 2006	Substantially Equivalent	Synthes (Usa)
K051047	COLLOSS E BONE VOID FILLER	Mar 08, 2006	Substantially Equivalent	Ossacur AG
K053319	ALLOMATRIX CUSTOM	Mar 06, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K051617	NOVABONE PUTTY - RESORBABLE BONE VOID FILLER	Mar 06, 2006	Substantially Equivalent	Novabone Products, LLC
K060061	STRYKER INJECTABLE CEMENT	Mar 01, 2006	Substantially Equivalent	Stryker Corp.
K060011	MIIG SR	Feb 27, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K053228	THERIGRAFT TCP PUTTY BONE VOID FILLER	Jan 31, 2006	Substantially Equivalent	Therics, LLC
K052812	OSSIMEND (TM) BONE GRAFT MATERIAL	Jan 25, 2006	Substantially Equivalent	Collagen Matrix, Inc.
K051774	MBCP	Jan 20, 2006	Substantially Equivalent	Biomatlante
K051603	STRYKER INJECTABLE CEMENT	Dec 30, 2005	Substantially Equivalent	Stryker Leibinger Micro Implants
K051386	MASTERGRAFT PUTTY BONE VOID FILLER	Dec 16, 2005	Substantially Equivalent	Medtronic Vascular
K051722	TRICOS T	Nov 18, 2005	Substantially Equivalent	Baxter Healthcare Corp
K052913	IGNITE BONE VOID FILLER KIT	Nov 07, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K052494	NOVABONE-BIOACTIVE SYNTHETIC GRAFT	Nov 03, 2005	Substantially Equivalent	Novabone Products, LLC
K051914	GENEROS 80, GENEROS 60	Nov 03, 2005	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K051698	MERRIES UNI-OSTEO, MODEL CS30250-CS10102	Sep 29, 2005	Substantially Equivalent	Merries International, Inc.
K051951	CERAMENT BONE VOID FILLER	Sep 28, 2005	Substantially Equivalent	Bonesupport AB
K052098	CONNEXUS, .5CC, MODEL 023000-005	Sep 07, 2005	Substantially Equivalent	Isotis Orthobiologics, Inc.
K051775	OSTEOMIMETIC SYNTHETIC BONE MATRIX	Sep 06, 2005	Substantially Equivalent	Biomimetic Pharmaceuticals, Inc.
K051615	STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES	Aug 15, 2005	Substantially Equivalent	Regeneration Technologies, Inc.
K051406	OSTEOCURE RESORBABLE BEAD KIT	Aug 01, 2005	Substantially Equivalent	Nexa Orthopedics, Inc.
K042125	AFT	Jul 28, 2005	Substantially Equivalent	Musculoskeletal Transplant Foundation
K051695	MARROW PLUS (M+)	Jul 19, 2005	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K050690	CONNEXUS	Jul 07, 2005	Substantially Equivalent	Isotis Orthobiologics, Inc.
K041177	SYNTHACER; SYNTRICER	Jun 23, 2005	Substantially Equivalent	Medartis Medizinprodukte Und Forschung AG
K051123	CALLOS IMPACT AND INJECT BONE VOID FILLER	Jun 03, 2005	Substantially Equivalent	Skeletal Kinetics, LLC
K050789	FORMAGRAFT COLLAGEN BONE GRAFT MATRIX	May 27, 2005	Substantially Equivalent	R and D Medical, LLC
K043005	MODIFICATION TO MBCP	May 03, 2005	Substantially Equivalent	Biomatlante
K050357	CAMCERAM TCP	Apr 21, 2005	Substantially Equivalent	Cam Implants B.V.
K050666	GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES	Apr 11, 2005	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K050490	OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER	Apr 11, 2005	Substantially Equivalent	Medicrea
K050416	OSSAPLAST ORTHO	Mar 29, 2005	Substantially Equivalent	Ossacur AG
K040419	DYNAGRAFT II	Mar 25, 2005	Substantially Equivalent	Isotis Orthobiologics, Inc.
K040262	DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX	Mar 17, 2005	Substantially Equivalent	Musculoskeletal Transplant Foundation
K031399	INTERGRO DBM	Feb 18, 2005	Substantially Equivalent	Interpore Cross Intl.
K043421	OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC	Feb 16, 2005	Substantially Equivalent	Regeneration Technologies, Inc.
K043308	MODIFICATION TO: HEALOS BONE GRAFT MATERIAL	Feb 16, 2005	Substantially Equivalent	Depuy Spine, Inc.
K043420	OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE	Feb 10, 2005	Substantially Equivalent	Regeneration Technologies, Inc.
K050025	NANOSS BONE VOID FILLER	Feb 03, 2005	Substantially Equivalent	Angstrom Medica, Inc.
K043514	ALLOGRAN-N-BONE VOID FILLER	Jan 21, 2005	Substantially Equivalent	Biocomposites, Ltd.
K043347	BF+	Jan 07, 2005	Substantially Equivalent	Ldr Spine USA
K043045	SYNTHES (USA) CHRONOS	Jan 07, 2005	Substantially Equivalent	Synthes (Usa)
K042911	CEMENTEK LV	Dec 27, 2004	Substantially Equivalent	Teknimed, S.A.
K040047	POLYGRAFT BGS; BONE GRAFT SUBSTITUTE	Dec 17, 2004	Substantially Equivalent	Osteobiologics, Inc.
K042636	BIOPLUS	Dec 14, 2004	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K042340	KASIOS TCP	Nov 24, 2004	Substantially Equivalent	Kasios Biomaterials
K042305	OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903	Oct 21, 2004	Substantially Equivalent	Ossacur AG
K041663	ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM	Sep 16, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K041089	OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM	Aug 31, 2004	Substantially Equivalent	Biomet Manufacturing, Inc.
K041421	NAME BONE VOID FILLER	Aug 26, 2004	Substantially Equivalent	Stryker Biotech
K041616	BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID	Aug 25, 2004	Substantially Equivalent	Orthos (Uk) Limited
K041613	NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE	Aug 25, 2004	Substantially Equivalent	Novabone Products, LLC
K041889	TRI-OSTETIC	Aug 19, 2004	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K041493	CEMENTEK	Aug 19, 2004	Substantially Equivalent	Teknimed, S.A.
K033707	POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX	Aug 16, 2004	Substantially Equivalent	Osteobiologics, Inc.
K040082	PORE-SI BONE GRAFT SUBSTITUTE	Aug 04, 2004	Substantially Equivalent	Apatech , Ltd.
K041168	ALLOMATRIX PUTTY	Aug 02, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K041842	NORIAN SRS FAST SET PUTTY	Jul 23, 2004	Substantially Equivalent	Synthes (Usa)
K040980	ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T	Jul 14, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K033679	COPSIOS BONE VOID FILLER (BVF)	Jul 07, 2004	Substantially Equivalent	Centerpulse Spine-Tech, Inc.
K040755	EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE	Jun 17, 2004	Substantially Equivalent	Exactech, Inc.
K033552	JAX-TCP	Jun 10, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K040381	HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15	May 12, 2004	Substantially Equivalent	Arthrex, Inc.
K040600	GENEX BONE GRAFT SUBSTITUTE	May 07, 2004	Substantially Equivalent	Biocomposites, Ltd.
K040454	BIOFILL BONE VOID FILLER	May 07, 2004	Substantially Equivalent	Scient'X
K033722	APAPORE BONE GRAFT SUBSTITUTE	May 07, 2004	Substantially Equivalent	Apatech , Ltd.
K040669	CERAFORM BONE VOID FILLER	May 03, 2004	Substantially Equivalent	Teknimed, S.A.
K040514	EOVIA CALCIUM PHOSPHATE CERAMIC	May 03, 2004	Substantially Equivalent	Ortho Tec, LLC
K033611	CALCIGEN -NAP BONE VOID FILLER	Apr 27, 2004	Substantially Equivalent	Biomet, Inc.
K022828	OSTEOSET DBM PELLETS, MODEL 8600-48XX	Apr 02, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K040216	CERASORB M ORTHO	Mar 26, 2004	Substantially Equivalent	Curasan AG
K040134	THERILINK BONE VOID FILLER	Mar 09, 2004	Substantially Equivalent	Therics, Inc.
K033258	BONESAVE BONE VOID FILLER	Mar 09, 2004	Substantially Equivalent	Howmedica Osteonics
K040405	CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY	Mar 05, 2004	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K020895	ALLOMATRIX MODEL# 86	Mar 05, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K020078	EXACTECH RESORBABLE BONE PASTE	Feb 27, 2004	Substantially Equivalent	Exactech, Inc.
K032288	VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL	Dec 19, 2003	Substantially Equivalent	Orthovita, Inc.
K032268	MBCP	Dec 11, 2003	Substantially Equivalent	Biomatlante
K033138	CAP3 BONE SUBSTITUTE MATERIAL	Dec 02, 2003	Substantially Equivalent	Etex Corp.
K031826	TRIHA +	Nov 28, 2003	Substantially Equivalent	Teknimed, S.A.
K032286	CALCIGEN PSI BONE GRAFT SUBSTITUTE	Nov 20, 2003	Substantially Equivalent	Biomet Orthopedics, Inc.
K032130	VITOSS-FILLED CARTRIDGE	Nov 05, 2003	Substantially Equivalent	Orthovita, Inc.
K031838	PROFUSION BONE VOID FILLER KIT	Oct 30, 2003	Substantially Equivalent	Biogeneration
K032409	VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER	Aug 29, 2003	Substantially Equivalent	Orthovita, Inc.
K031651	MODIFICATION TO CERASORB ORTHO	Aug 13, 2003	Substantially Equivalent	Curasan AG
K031435	BONESOURCE BVF	Aug 04, 2003	Substantially Equivalent	Howmedica Osteonics
K031040	THERIFIL BONE FILLER	Jul 24, 2003	Substantially Equivalent	Therics, Inc.
K031817	CELLPLEX TCP SYNTHETIC CANCELLOUS BONE	Jul 17, 2003	Substantially Equivalent	Wrightmedicaltechnologyinc
K031319	OSTEO-G BONE VOID FILLER SYSTEM	Jul 17, 2003	Substantially Equivalent	Aspine USA, Inc.
K030288	POLYGRAFT BONE GRAFT SUBSTITUTE	Jul 17, 2003	Substantially Equivalent	Osteobiologics, Inc.
K030554	CALLOS	May 20, 2003	Substantially Equivalent	Skeletal Kinetics, LLC
K030131	OSSATURA BCP BONE VOID FILLER	May 20, 2003	Substantially Equivalent	Isotis NV
K023553	MASTERGRAFT MATRIX	Apr 22, 2003	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K024336	MIIG II BONE GRAFT SUBSTITUTE	Mar 04, 2003	Substantially Equivalent	Wrightmedicaltechnologyinc
K030178	CALCIGEN PSI BONE GRAFT SUBSTITUTE	Feb 26, 2003	Substantially Equivalent	Biomet, Inc.
K010555	JAX	Feb 25, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K030266	CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ	Feb 20, 2003	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K023703	BI-OSTETIC	Jan 30, 2003	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K021963	BIOSORB RESORBABLE VOID FILLER	Jan 28, 2003	Substantially Equivalent	Sciences ET Bio Materiaux (Sbm)
K022622	CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P	Jan 09, 2003	Substantially Equivalent	Berkeley Advanced Biomaterials, Inc.
K023862	NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER	Dec 19, 2002	Substantially Equivalent	Synthes (Usa)
K013072	CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)	Nov 26, 2002	Substantially Equivalent	Synthes
K022629	WMT-TCP BONE GRAFT SUBSTITUTE	Nov 05, 2002	Substantially Equivalent	Wrightmedicaltechnologyinc
K021551	STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT	Nov 01, 2002	Substantially Equivalent	Biocomposites, Ltd.
K011531	CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER	Sep 06, 2002	Substantially Equivalent	Biomet, Inc.
K021336	NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE	Jul 25, 2002	Substantially Equivalent	Novabone Products, LLC
K020986	MASTERGRAFT RESORBABLE CERAMIC	Jul 22, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K013790	CALCIGEN-S BONE VOID FILER	Jun 11, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K013960	APATIGHT HA-BONE GRAFT SUBSTITUTE	May 23, 2002	Substantially Equivalent	Cerabio, LLC
K013966	APATIGHT-TCP BONE GRAFT SUBSTITUTE	May 16, 2002	Substantially Equivalent	Cerabio, LLC
K011726	MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER	May 16, 2002	Substantially Equivalent	Millenium Biologix, Inc.
K014156	CERASORB ORTHO	Mar 18, 2002	Substantially Equivalent	Curasan AG
K014053	CONDUIT TCP GRANULES	Mar 08, 2002	Substantially Equivalent	Depuyacromed
K012506	MASTERGRAFT RESORBABLE CERAMIC GRANULES	Mar 07, 2002	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K011897	NORIAN SRS BONE VOID FILLER	Dec 20, 2001	Substantially Equivalent	Synthes (Usa)
K012751	HEALOS BONE GRAFT MATERIAL	Nov 14, 2001	Substantially Equivalent	Orquest, Inc.
K011048	BSM BONE SUBSTITUTE MATERIAL	Nov 13, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K010532	OSTEOSET BVF KIT	Oct 26, 2001	Substantially Equivalent	Wrightmedicaltechnologyinc
K000122	COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)	Sep 20, 2001	Substantially Equivalent	Neucoll, Inc.
K011386	EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE	Aug 03, 2001	Substantially Equivalent	Ebi, L.P.
K004003	PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30	Jul 19, 2001	Substantially Equivalent	Interpore Cross Intl.
K003954	STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT	Jul 12, 2001	Substantially Equivalent	Biocomposites, Ltd.
K010557	JAX GRANULES BONE VOID FILLER	May 25, 2001	Substantially Equivalent	Smith & Nephew, Inc.
K994337	VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER	Dec 14, 2000	Substantially Equivalent	Orthovita Co.
K002362	SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)	Nov 01, 2000	Substantially Equivalent	Synthes (Usa)
K000515	PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,	Sep 15, 2000	Substantially Equivalent	Interpore Cross Intl.
K001724	STIMULAN -CALCIUM SULFATE BONE VOID FILTER	Aug 04, 2000	Substantially Equivalent	Biocomposites, Ltd.
K001559	CALCIUM SULFATE PELLETS	Jun 20, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K991854	OSTEOPLAST, MODEL POP200	Aug 26, 1999	Substantially Equivalent	Interpore Cross Intl.
K990131	PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE	Mar 02, 1999	Substantially Equivalent	Interpore Cross Intl.
K982663	STIMULAN- CALCIUM SULFATE BONE VOID FILLER	Feb 26, 1999	Substantially Equivalent	Encore Orthopedics, Inc.
K980817	PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L	Sep 25, 1998	Substantially Equivalent	Interpore Intl.
K973704	PROFUSION BONE VOID FILLER	Apr 03, 1998	Substantially Equivalent	Biogeneration
K963562	WRIGHT PLASTER OF PARIS PELLETS	May 07, 1997	Substantially Equivalent	Wrightmedicaltechnologyinc
K963587	WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)	Mar 24, 1997	Substantially Equivalent	Wrightmedicaltechnologyinc
K960978	WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)	Jun 21, 1996	Substantially Equivalent	Wrightmedicaltechnologyinc