Product Code: KWP FDA class 2 21 CFR 888.3050

Appliance, Fixation, Spinal Interlaminal

Orthopedic

The Spinal Interlaminal Fixation Appliance is an orthopedic implant attached to the laminae of adjacent vertebrae to provide posterior spinal stabilization, used in the treatment of spinal instability, deformity, or following decompression surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWP, regulated under 21 CFR 888.3050, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

430

FEI Numbers

321

Registration Numbers

321

Unique Applicants

142

Years Active

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Basic Information

Product Code: KWP
Device Class: FDA class 2
Regulation Number: 888.3050
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 430 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K143278	LnK Posterior Cervical Fixation System	Jul 29, 2015	Substantially Equivalent	L&K BIOMED Co., Ltd.
K150753	OASYS System	Jun 09, 2015	Substantially Equivalent	Stryker Corporation
K150851	Sure Lok Mini Posterior Cervical/Upper Thoracic System	Jun 04, 2015	Substantially Equivalent	Precision Spine, Inc.
K142867	Reliance Posterior Cervical-Thoracic System	Apr 29, 2015	Substantially Equivalent	Reliance Medical Systems, LLC
K150254	Streamline OCT Occipito-Cervico-Thoracic System	Apr 28, 2015	Substantially Equivalent	Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
K142253	SOLSTICE OCT System	Apr 23, 2015	Substantially Equivalent	Life Spine, Inc.
K150229	SOLSTICE OCT System	Apr 07, 2015	Substantially Equivalent	Life Spine, Inc.
K143249	SOLSTICE OCT System	Apr 07, 2015	Substantially Equivalent	Life Spine, Inc.
K142741	OASYS System	Jan 15, 2015	Substantially Equivalent	Stryker Corporation
K142558	Caspian OCT/MESA Mini/DENALI Mini Spinal System	Dec 22, 2014	Substantially Equivalent	K2m
K140734	NEXTGEN ALTIUS OCT SYSTEM	Dec 15, 2014	Substantially Equivalent	Ebi, LLC
K142460	EXPEDIUM Spine System/Synapse System	Oct 01, 2014	Substantially Equivalent	Johnson and Johnson
K141897	SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM	Sep 25, 2014	Substantially Equivalent	Synthes USA Products, LLC
K141284	CASPIAN SPINAL SYSTEM	Jul 23, 2014	Substantially Equivalent	K2m, Inc.
K133288	CASPIAN OCT SPINAL SYSTEM	Jul 01, 2014	Substantially Equivalent	K2m, Inc.
K133556	VIRAGE OCT SPINAL FIXATION SYSTEM	Jun 02, 2014	Substantially Equivalent	Zimmer Spine, Inc.
K140645	GIBRALT ROD-TO-ROD CROSS CONNECTORS	Apr 11, 2014	Substantially Equivalent	Exactech Sarasota
K133374	STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM	Mar 19, 2014	Substantially Equivalent	Pioneer Surgical Technology, Inc. (Rti Surgical, I
K133214	BLACKBIRD SPINAL SYSTEM	Mar 07, 2014	Substantially Equivalent	Choicespine, LP
K131833	CENTURION POCT SYSTEM	Jan 30, 2014	Substantially Equivalent	Orthofix, Inc.
K132122	KESTREL POSTERIOR CERVICAL SPINE SYSTEM	Jan 22, 2014	Substantially Equivalent	Omni Surgical, LLC Dba Spine360
K133698	SYNAPSE SYSTEM	Jan 16, 2014	Substantially Equivalent	Synthes USA Products, LLC
K133094	CERTEX OCT SPINAL IMPLANT SYSTEM	Dec 11, 2013	Substantially Equivalent	X-Spine Systems, Inc.
K132504	TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM	Nov 25, 2013	Substantially Equivalent	Corelink, LLC
K132900	MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM	Oct 25, 2013	Substantially Equivalent	Intelligent Implant Systems, LLC
K131427	LOTUS	Oct 24, 2013	Substantially Equivalent	Spinal Elements, Inc.
K132332	MOUNTAINEER OCT SPINAL SYSTEM	Aug 22, 2013	Substantially Equivalent	Medos International SARL
K131156	LANX SPINAL FIXATION SYSTEM	May 24, 2013	Substantially Equivalent	Lanx, Inc.
K123906	VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM	Apr 01, 2013	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K121979	PASS OCT SPINAL SYSTEM	Mar 21, 2013	Substantially Equivalent	Medicrea International
K123783	ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS	Mar 14, 2013	Substantially Equivalent	Globus Medical, Inc.
K123656	VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM	Feb 25, 2013	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K121877	GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES	Feb 12, 2013	Substantially Equivalent	Exactech, Inc.
K123232	SPINEOLOGY SPINOUS PROCESS PLATE	Feb 07, 2013	Substantially Equivalent	Spineology, Inc.
K123093	STABILINK MIS SPINAL FIXATION SYSTEM	Dec 20, 2012	Substantially Equivalent	Southern Spine, LLC
K123568	VERTEX RECONSTRUCTION SYSTEM	Dec 18, 2012	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K122509	VERTIFLEX SPINOUS PROCESS FIXATION PLATE	Dec 17, 2012	Substantially Equivalent	Vertiflex, Inc.
K121725	PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM	Nov 07, 2012	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K122292	RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM	Oct 24, 2012	Substantially Equivalent	Reliance Medical Systems, LLC
K120998	SOLSTICE CROSS CONNECTOR	Oct 01, 2012	Substantially Equivalent	Life Spine
K122378	NEXTGEN ALTIUS OCT SYSTEM	Sep 20, 2012	Substantially Equivalent	Biomet Spine (Aka Ebi, LLC)
K121136	RENOIR POSTERIOR CERVIAL FIXATION SYSTEM	Aug 09, 2012	Substantially Equivalent	Accel Spine
K121808	CASIAN, 3.5/4.5 CONNECTORS	Jul 20, 2012	Substantially Equivalent	K2m, Inc.
K121115	M.U.S.T PEDICLE SCREW SYSTEM	Jul 18, 2012	Substantially Equivalent	Medacta International
K121191	VERTEX RCCONSTRUCTION SYSTEM	Jun 29, 2012	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K113593	NEXTGEN ALTIUS OCT SYSTEM	Apr 17, 2012	Substantially Equivalent	Biomet Spine (Aka Ebi, LLC)
K113324	REXIOUS HOOK FIXATION SYSTEMS	Mar 28, 2012	Substantially Equivalent	Dio Medical Co., Ltd.
K112757	PIONEER POSTERIOR CERVICO THORACIC SYSTEM	Mar 12, 2012	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K113346	NEON SYSTEM	Feb 28, 2012	Substantially Equivalent	Ulrich GmbH & Co. KG
K112595	COFLEX-F	Feb 13, 2012	Substantially Equivalent	Paradigm Spine, LLC
K111719	OASYS SPINAL SYSTEM	Jan 19, 2012	Substantially Equivalent	Stryker Spine
K113654	CASPIAN	Jan 12, 2012	Substantially Equivalent	K2m, Inc.
K112592	AXLE PEEK INTERSPINOUS FUSION SYSTEM	Dec 05, 2011	Substantially Equivalent	X-Spine Systems, Inc.
K112025	SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM	Sep 15, 2011	Substantially Equivalent	Spinal USA
K103205	BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM	Jun 02, 2011	Substantially Equivalent	Alphatec Spine, Inc.
K111183	ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)	May 24, 2011	Substantially Equivalent	Orthofix, Inc.
K110963	ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM	May 05, 2011	Substantially Equivalent	Globus Medical, Inc.
K103091	LANX SPINAL FIXATION SYSTEM	Apr 15, 2011	Substantially Equivalent	Lanx, Inc.
K110353	MOUNTAINEER OCT SPINAL SYSTEM	Apr 07, 2011	Substantially Equivalent	Depuy Spine, Inc.
K110522	VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM	Apr 01, 2011	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K110367	PIONEER SPINAL PROCESS FUSION PLATE	Mar 23, 2011	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K102886	CD HORIZON SPINAL SYSTEM	Jan 26, 2011	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K102195	SP-FIX SPINOUS PROCESS FIXATION PLATE	Jan 19, 2011	Substantially Equivalent	Globus Medical, Inc.
K103232	CASPIAN SPINAL SYSTEM	Jan 13, 2011	Substantially Equivalent	K2m, Inc.
K101471	AXLE INTERSPINOUS FUSION SYSTEM	Nov 24, 2010	Substantially Equivalent	X-Spine Systems, Inc.
K100888	MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM	Nov 15, 2010	Substantially Equivalent	Lanx, Inc.
K101183	MODIFICATION TO: OASYS SYSTEM	Nov 09, 2010	Substantially Equivalent	Stryker Spine
K101112	RELIANCE SPINAL SCREW SYSTEM	Nov 04, 2010	Substantially Equivalent	Reliance Medical Systems
K101525	PIONEER SPINOUS PROCESS FUSION PLATE	Oct 22, 2010	Substantially Equivalent	Pioneer Surgical Technology
K093438	PARADIGM INTERSPINOUS FUSION PLATE	Oct 06, 2010	Substantially Equivalent	Paradigm Spine, LLC
K101084	CASPIAN SPINAL SYSTEM	Oct 04, 2010	Substantially Equivalent	K2m, Inc.
K102020	VEGA SPAN SPINOUS PROCESS PLATE SYSTEM	Sep 01, 2010	Substantially Equivalent	Spinefrontier, Inc.
K100354	PRIMAL OK INTERSPINOUS FUSION SYSTEM	Aug 17, 2010	Substantially Equivalent	Osteomed LP
K093319	NUVASIVE VUEPOINT OCT SYSTEM	Jun 23, 2010	Substantially Equivalent	Nuvasive, Inc.
K100685	ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM	Jun 18, 2010	Substantially Equivalent	Alphatec Spine, Inc.
K100191	LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)	Apr 15, 2010	Substantially Equivalent	Lanx, Inc.
K092825	APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER	Mar 16, 2010	Substantially Equivalent	Spinecraft, Inc.
K092295	PIONEER POSTERIOR CERVICO-THORACIC SYSTEM	Feb 19, 2010	Substantially Equivalent	Pioneer Surgical Technology
K093534	MODIFICATION TO CASPIAN SPINAL SYSTEM	Dec 16, 2009	Substantially Equivalent	K2m, Inc.
K092656	LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM	Nov 24, 2009	Substantially Equivalent	Lanx, Inc.
K091359	GSO PCT SPINAL SYSTEM	Sep 02, 2009	Substantially Equivalent	Gold Standard Orthopaedics, LLC
K090343	SENTINEL SPINAL SYSTEM	Aug 11, 2009	Substantially Equivalent	Life Spine
K091365	VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM	Aug 06, 2009	Substantially Equivalent	Medtronic Soafamor Danek
K091689	SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM	Jul 10, 2009	Substantially Equivalent	Synthes (Usa)
K090565	ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM	Jun 30, 2009	Substantially Equivalent	Globus Medical, Inc.
K090060	NEXLINK OCT SYSTEM, MODEL 7000 SERIES	Jun 02, 2009	Substantially Equivalent	Abbott Spine, Inc.
K090549	SYNTHES SYNAPSE TRANSCONNECTOR	May 21, 2009	Substantially Equivalent	Synthes Spine
K090714	VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM	Apr 17, 2009	Substantially Equivalent	Medtronic Sofamor Danek
K090252	MODIFICATION TO: LANX SPINAL FIXATION SYSTEM	Mar 04, 2009	Substantially Equivalent	Lanx, Inc.
K082728	VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM	Jan 16, 2009	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K082769	MESA AND RANGE SPINAL SYSTEMS	Dec 11, 2008	Substantially Equivalent	K2m, Inc.
K083071	VERTEX RECONSTRUCTION SYSTEM	Nov 14, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K081906	PROTEX CT CERVICOTHORACIC SPINAL SYSTEM	Nov 14, 2008	Substantially Equivalent	Globus Medical, Inc.
K081107	CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS	Oct 10, 2008	Substantially Equivalent	K2m, Inc.
K081297	VERTEX RECONSTRUCTION SYSTEM	Jun 11, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K080790	MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM	Apr 29, 2008	Substantially Equivalent	Theken Spine, LLC
K080805	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Apr 18, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K072729	SIERRA	Apr 17, 2008	Substantially Equivalent	Seaspine, Inc.
K080526	SIERRA SYSTEM	Apr 16, 2008	Substantially Equivalent	Seaspine, Inc.
K073278	SPINOUS PROCESS PLATE SYSTEM	Mar 28, 2008	Substantially Equivalent	Nuvasive, Inc.
K080394	BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM	Mar 13, 2008	Substantially Equivalent	Blackstone Medical, Inc.
K073420	BLACKSTONE ASCENT MULTIAXIAL SCREWS	Feb 14, 2008	Substantially Equivalent	Blackstone Medical, Inc.
K073654	BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR	Jan 24, 2008	Substantially Equivalent	Blackstone Medical, Inc.
K072866	ISSYS LP SPINAL FIXATION SYSTEM	Dec 13, 2007	Substantially Equivalent	Custom Spine, Inc.
K071942	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Dec 11, 2007	Substantially Equivalent	Medtronic Sofamor Danek
K072081	ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM	Oct 24, 2007	Substantially Equivalent	Alphatec Spine, Inc.
K062447	TRAVERSE OCT SPINAL FIXATION SYSTEM	Oct 15, 2007	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K072568	MODIFICATION TO OASYS SYSTEM	Oct 05, 2007	Substantially Equivalent	Stryker Spine
K070742	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Sep 14, 2007	Substantially Equivalent	Medtronic Sofamor Danek
K071633	LANX DEFORMITY SYSTEM	Aug 15, 2007	Substantially Equivalent	Lanx, LLC
K070341	LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM	Aug 08, 2007	Substantially Equivalent	Ldr Spine USA
K071377	POLARIS BE RODS	Aug 06, 2007	Substantially Equivalent	Biomet Spine
K070966	GSO GS1 SPINAL SYSTEM	Jul 20, 2007	Substantially Equivalent	Gold Standard Orthopaedics, LLC
K070638	THEKEN ATOLL CERVICO-THORACIC SYSTEM	May 30, 2007	Substantially Equivalent	Theken Spine, LLC
K061943	ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM	May 25, 2007	Substantially Equivalent	Anatomica AB
K070300	EXPEDIUM SFX CROSS CONNECTOR SYSTEM	Apr 10, 2007	Substantially Equivalent	Depuy Spine, Inc.
K062181	C-JAWS CERVICAL COMPRESSIVE MINI FRAME	Jan 16, 2007	Substantially Equivalent	Medicrea Technologies
K062785	LTD POLYAXIAL FIXATION SYSTEM	Dec 26, 2006	Substantially Equivalent	Us Spine
K062513	APEX SPINE SYSTEM	Dec 22, 2006	Substantially Equivalent	Spinecraft, Inc.
K061591	MODIFICATION TO CD HORIZON SPINAL SYSTEM	Sep 08, 2006	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K053418	SYNTHES OC FUSION SYSTEM	Sep 06, 2006	Substantially Equivalent	Synthes Spine Co.Lp
K061579	MODIFICATION TO CD HORIZON SPINAL SYSTEM	Aug 11, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K052404	DENALI DEFORMITY SYSTEM	May 23, 2006	Substantially Equivalent	K2m, LLC
K060683	ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM	Apr 18, 2006	Substantially Equivalent	Endius, Inc.
K060513	SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X	Mar 10, 2006	Substantially Equivalent	Sintea Biotech, Inc.
K060081	BASIS SPINAL SYSTEM	Feb 13, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K052201	SOLANAS POSTERIOR STABILIZATION SYSTEM	Nov 10, 2005	Substantially Equivalent	Alphatec Spine, Inc.
K052734	MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM	Oct 21, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K052131	EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS	Sep 28, 2005	Substantially Equivalent	Depuy Spine, Inc.
K052402	VERTEX RECONSTRUCTION SYSTEM	Sep 23, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K052376	MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM	Sep 23, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K052123	SYNTHES PANGEA SYSTEM	Sep 23, 2005	Substantially Equivalent	Synthes (Usa)
K052247	NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX	Sep 14, 2005	Substantially Equivalent	Abbott Spine, Inc.
K052181	MODIFICATION TO XIA SPINAL SYSTEM	Sep 08, 2005	Substantially Equivalent	Stryker Spine
K051716	VERTEBRON PSS PEDICLE SCREW SYSTEM	Sep 07, 2005	Substantially Equivalent	Vertebron, Inc.
K052180	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Aug 23, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K051973	MODIFICATION TO: XIA STAINLESS STEEL SYSTEM	Aug 18, 2005	Substantially Equivalent	Stryker Spine
K052069	PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES	Aug 17, 2005	Substantially Equivalent	Globus Medical, Inc.
K051942	MALIBU SPINAL SYSTEM	Jul 27, 2005	Substantially Equivalent	Seaspine, Inc.
K050391	PROTEX CT CERVICOTHORACIC SPINAL SYSTEM	Jul 21, 2005	Substantially Equivalent	Globus Medical, Inc.
K050830	ZODIAC SPINAL FIXATION SYSTEM	Jun 22, 2005	Substantially Equivalent	Alphatec/Nexmed
K050809	CD HORIZON SPINAL SYSTEM	Jun 14, 2005	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K050484	BASIS SPINAL SYSTEM	May 04, 2005	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K043053	MODIFICATION TO CD HORIZON SPINAL SYSTEM	Apr 11, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K050189	TECHTONIX SYSTEM	Feb 16, 2005	Substantially Equivalent	Stryker Spine
K050079	CD HORIZON SPINAL SYSTEM	Feb 10, 2005	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K043522	ISSYS PEDICLE SCREW SYSTEM	Jan 14, 2005	Substantially Equivalent	Custom Spine, Inc.
K043473	MODIFICATION TO XIA SPINAL SYSTEM	Jan 12, 2005	Substantially Equivalent	Stryker Spine
K042635	DENALI SPINE SYSTEM	Jan 10, 2005	Substantially Equivalent	K2m, LLC
K043020	GLAXY 3.2 SPINAL SYSTEM	Jan 07, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K043229	MODIFICATION TO ALTIUS OCT SYSTEM	Dec 21, 2004	Substantially Equivalent	Interpore Cross Intl.
K042789	VERTEX RECONSTRUCTION SYSTEM	Dec 21, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K043355	SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X	Dec 17, 2004	Substantially Equivalent	Sintea Biotech, Inc.
K042673	ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM	Oct 27, 2004	Substantially Equivalent	Alphatec/Nexmed
K042524	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Oct 08, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K042508	SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM	Oct 07, 2004	Substantially Equivalent	Depuy Spine, Inc.
K042498	VERTEX RECONSTRUCTION SYSTEM	Oct 07, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K042143	EXCELLA-M SPINAL SYSTEM	Oct 07, 2004	Substantially Equivalent	Innovasis, Inc.
K042402	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Oct 01, 2004	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K041808	ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM	Oct 01, 2004	Substantially Equivalent	Endius, Inc.
K041925	ST360 SPINAL FIXATION SYSTEM	Sep 24, 2004	Substantially Equivalent	Zimmer Spine, Inc.
K041592	CORAL SPINAL SYSTEM	Sep 16, 2004	Substantially Equivalent	Theken Surgical
K041862	CD HORIZON SPINAL SYSTEM	Sep 15, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K041119	EXPEDIUM SPINE SYSTEM	Jul 19, 2004	Substantially Equivalent	Depuy Spine, Inc.
K041449	SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT	Jul 01, 2004	Substantially Equivalent	Interpore Cross Intl.
K040096	SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM	Jul 01, 2004	Substantially Equivalent	Spinal Concepts, Inc.
K041282	MODIFICATION TO TSRH SPINAL SYSTEM	Jun 10, 2004	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K033961	ALTIUS OCT SYSTEM	Apr 14, 2004	Substantially Equivalent	Interpore Cross Intl.
K033090	ICON POLYAXIAL PEDICLE SCREW SYSTEM	Mar 26, 2004	Substantially Equivalent	Alphatec Mfg., Inc.
K033980	BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)	Mar 03, 2004	Substantially Equivalent	Blackstone Medical, Inc.
K032094	PASSMED SPINAL SYSTEM	Nov 14, 2003	Substantially Equivalent	Medicrea
K031175	CLICK'X MONOAXIAL SCREWS AND HOOKS	Nov 14, 2003	Substantially Equivalent	Synthes (Usa)
K031471	ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01	Oct 10, 2003	Substantially Equivalent	Ortho Tec, LLC
K031772	TI FENESTRATED PLATE	Sep 05, 2003	Substantially Equivalent	Interpore Cross Intl.
K023884	MODIFICATION ORIA SPINAL SYSTEM	Aug 20, 2003	Substantially Equivalent	Ortho Tec, LLC
K031893	XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM	Jul 17, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K031595	U & I AMERICA SPINAL HOOK SYSTEM	Jun 24, 2003	Substantially Equivalent	U&I Corp., America
K030875	MODIFICATION TO COLORADO 2 SPINAL SYSTEM	Jun 24, 2003	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K031452	ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03	Jun 18, 2003	Substantially Equivalent	Ortho Tec, LLC
K031533	VANTAGE ANTERIOR FIXATION SYSTEM	Jun 13, 2003	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K030197	BLACKSTONE POSTERIOR CERVICAL SYSTEM	Jun 12, 2003	Substantially Equivalent	Blackstone Medical, Inc.
K030816	MSD CABLE REDUCTION SYSTEM	Jun 06, 2003	Substantially Equivalent	Medtronic Sofamor Danek
K031090	MODIFICATION TO XIA STAINLESS STEEL SYSTEM	Apr 24, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K030253	ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06	Feb 21, 2003	Substantially Equivalent	Ortho Tec, LLC
K030252	ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)	Feb 21, 2003	Substantially Equivalent	Ortho Tec, LLC
K030241	MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM	Feb 21, 2003	Substantially Equivalent	Blackstone Medical, Inc.
K023804	MOSS MIAMI SPINAL SYSTEM PIN NUT	Jan 23, 2003	Substantially Equivalent	Depuyacromed
K023797	LAURAIN DEWALD ANTERIOR FIXATION SYSTEM	Dec 13, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K023415	MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM	Dec 13, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K014296	CD HORIZON SPINAL SYSTEM	Dec 10, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K022048	INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM	Dec 04, 2002	Substantially Equivalent	Interpore Cross Intl.
K023675	SYNTHES CERVIFIX/ AXON	Nov 26, 2002	Substantially Equivalent	Synthes (Usa)
K023555	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Nov 22, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K021679	ORIA SPINAL CLIP SYSTEM	Nov 19, 2002	Substantially Equivalent	Ortho Tec, LLC
K023498	MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM	Nov 13, 2002	Substantially Equivalent	Blackstone Medical, Inc.
K022374	CADENCE SPINAL FIXATION SYSTEM	Sep 24, 2002	Substantially Equivalent	Sulzer Spine-Tech
K022191	MODIFICATION TO TENOR SPINAL SYSTEM	Aug 28, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K022623	5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)	Aug 27, 2002	Substantially Equivalent	Depuyacromed
K021507	PLUS PIVOT LINK UNIVERSAL SYSTEM	Aug 01, 2002	Substantially Equivalent	Spine Vision, Inc.
K021061	MODIFICATION TO CD HORIZON SPINAL SYSTEM	Jul 25, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K022070	XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM	Jul 22, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K022015	MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM	Jul 18, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K021170	TSRH SPINAL SYSTEM	Jul 09, 2002	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K021919	SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO	Jul 03, 2002	Substantially Equivalent	Ortho Tec, LLC
K021825	MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM	Jul 01, 2002	Substantially Equivalent	Unitedstates Surgical
K021009	OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM	Jun 18, 2002	Substantially Equivalent	Spinal Concepts, Inc.
K020709	MODIFICATION TO CD HORIZON SPINAL SYSTEM	May 09, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K020134	SPIRAL RADIUS 90-D RODDING SYSTEM	Apr 15, 2002	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K014090	ENDIUS SPINAL FIXATION SYSTEM	Mar 11, 2002	Substantially Equivalent	Endius, Inc.
K020426	MSD WIRE SYSTEM	Feb 26, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K020236	MODIFICATION TO PASS SPINAL SYSTEM	Feb 14, 2002	Substantially Equivalent	Encore Orthopedics, Inc.
K013312	P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)	Feb 13, 2002	Substantially Equivalent	Spine Vision, Inc.
K020155	DYNA-LOK CLASSIC SPINAL SYSTEM	Feb 05, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K013196	ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM	Jan 30, 2002	Substantially Equivalent	Spinal Innovations, LLC
K014267	BUTTERFLY PLATE FIXATION SYSTEM	Jan 25, 2002	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K013447	ISOBAR SPINAL SYSTEM	Jan 15, 2002	Substantially Equivalent	Scien'Tx USA, Inc.
K013442	PASS SPINAL SYSTEM	Jan 15, 2002	Substantially Equivalent	Encore Orthopedics, Inc.
K013823	XIA SPINAL SYSTEM	Dec 19, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K012516	EBI SPINELINK - II SPINAL FIXATION SYSTEM	Nov 27, 2001	Substantially Equivalent	Ebi, L.P.
K013441	ISOLA POLYAXIAL WASHER	Nov 16, 2001	Substantially Equivalent	Depuyacromed
K012173	DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM	Sep 28, 2001	Substantially Equivalent	Sulzer Spine-Tech
K003780	VERTEX RECONSTRUCTION SYSTEM	Sep 28, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K012870	XIA STAINLESS STEEL SYSTEM	Sep 24, 2001	Substantially Equivalent	Howmedica Osteonics Corp.
K012871	SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177	Sep 13, 2001	Substantially Equivalent	Interpore Cross Intl.
K011830	TRI-FIX SPINAL FIXATION SYSTEM	Jul 23, 2001	Substantially Equivalent	Endius, Inc.
K011969	SYNTHES CERVIFIX SYSTEM	Jul 19, 2001	Substantially Equivalent	Synthes (Usa)
K010681	SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM	Jul 18, 2001	Substantially Equivalent	Depuyacromed
K003823	SCS DT-02 TRANSVERSE CONNECTOR	Jul 11, 2001	Substantially Equivalent	Ortho Tec, LLC
K011508	CD HORIZON SPINAL SYSTEM	Jun 12, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K010181	CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION	Jun 12, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K010632	BUTTERFLY PLATE FUNCTION SYSTEM	May 31, 2001	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K010515	MODIFICATION TO SYNERGY SPINAL SYSTEM	Mar 22, 2001	Substantially Equivalent	Interpore Cross Intl.
K001535	ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION	Mar 20, 2001	Substantially Equivalent	Ortho Tec, LLC
K003911	TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)	Mar 13, 2001	Substantially Equivalent	Terray Corp.
K003351	PARSFIX CABLE-SCREW SYSTEM	Jan 24, 2001	Substantially Equivalent	Spinal Concepts, Inc.
K003822	ISOLA CLOSED DUAL ROD CONNECTOR	Jan 08, 2001	Substantially Equivalent	Depuyacromed
K002733	SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM	Dec 15, 2000	Substantially Equivalent	Depuyacromed
K002059	AMT SPINAL SYSTEM	Nov 13, 2000	Substantially Equivalent	Micron Precision Engineering, Inc.
K002103	SIMPLICITY SPINAL SYSTEM	Nov 02, 2000	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K002959	MODIFICATION TO ISOBAR SPINAL SYSTEM	Oct 16, 2000	Substantially Equivalent	Encore Orthopedics, Inc.
K002082	SPEEDLINK TRANSVERSE CONNECTOR	Oct 06, 2000	Substantially Equivalent	Spinal Concepts, Inc.
K002505	XIA SPINE SYSTEM	Oct 05, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K002069	ASCEND SPINAL FIXATION SYSTEM	Oct 05, 2000	Substantially Equivalent	Spinal Innovations, LLC
K002607	MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS	Sep 12, 2000	Substantially Equivalent	Depuyacromed
K002517	USS VAS	Sep 12, 2000	Substantially Equivalent	Synthes (Usa)
K001653	XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY	Aug 18, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K001470	E-Z LINK CROSS CONNECTOR	Aug 04, 2000	Substantially Equivalent	Depuyacromed
K001372	E-Z LINK CROSS CONNECTOR	Jul 27, 2000	Substantially Equivalent	Depuyacromed
K001080	SPINE SYSTEM EVOLUTION	Jun 29, 2000	Substantially Equivalent	Aesculap, Inc.
K001532	DYNA-LOK CLASSIC SPINAL SYSTEM	Jun 16, 2000	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K001105	MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS	Apr 24, 2000	Substantially Equivalent	Depuyacromed
K994187	SYNTHES CERVIFIX SYSTEM	Dec 21, 1999	Substantially Equivalent	Synthes (Usa)
K992885	VERSALOK LOW BACK FIXATION SYSTEM	Nov 19, 1999	Substantially Equivalent	Osteotech, Inc.
K993067	SILHOUETTE SPINAL FIXATION SYSTEM	Nov 16, 1999	Substantially Equivalent	Sulzer Spine-Tech
K991662	TITANIUM HARTSHILL SYSTEM	Nov 08, 1999	Substantially Equivalent	Surgicraft , Ltd.
K990986	CONTOUR SPINAL SYSTEM	Oct 14, 1999	Substantially Equivalent	Ortho Development Corp.
K991198	DYNA-LOK PLUS SPINAL SYSTEM	Aug 27, 1999	Substantially Equivalent	Sofamor Danek USA,Inc.
K991089	SYNTHES CERVIFIX SYSTEM	Aug 27, 1999	Substantially Equivalent	Synthes Spine
K991586	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	Jul 23, 1999	Substantially Equivalent	Osteotech, Inc.
K990965	SYNTHES CERVIFIX SYSTEM	Jul 01, 1999	Substantially Equivalent	Synthes (Usa)
K990922	OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR	Jun 02, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K984375	OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY	Apr 30, 1999	Substantially Equivalent	Osteonics Corp.
K990303	EBI OMEGA 21 SYSTEM	Apr 29, 1999	Substantially Equivalent	Electro-Biology, Inc.
K990845	MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15	Apr 13, 1999	Substantially Equivalent	Advanced Spine Fixation Systems, Inc.
K990708	TITANIUM VERSALOK	Mar 30, 1999	Substantially Equivalent	Wrightmedicaltechnologyinc
K981676	CD HORIZON SPINAL SYSTEM	Jan 28, 1999	Substantially Equivalent	Sofamor Danek USA,Inc.
K984377	SYNTHES SPINE CERVIFIX SYSTEM	Jan 21, 1999	Substantially Equivalent	Synthes (Usa)
K983904	ROGOZINSKI SPINAL ROD SYSTEM	Dec 22, 1998	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K983353	SCS SPINAL SYSTEM	Dec 18, 1998	Substantially Equivalent	Orthotec, Inc.
K983530	SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM	Dec 16, 1998	Substantially Equivalent	Synthes (Usa)
K983583	DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS	Dec 03, 1998	Substantially Equivalent	Depuy, Inc.
K982322	SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM	Nov 25, 1998	Substantially Equivalent	Synthes (Usa)
K983282	OMI OCCIPITAL CERVICAL LOOP, MODEL A1089	Nov 19, 1998	Substantially Equivalent	Ohio Medical Instrument Co., Inc.
K983706	MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM	Nov 12, 1998	Substantially Equivalent	Sofamor Danek USA,Inc.
K983197	SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)	Oct 26, 1998	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K982490	TENOR SPINAL SYSTEM	Oct 05, 1998	Substantially Equivalent	Sofamor Danek USA,Inc.
K982511	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS	Sep 14, 1998	Substantially Equivalent	Depuy, Inc.
K982320	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM	Sep 14, 1998	Substantially Equivalent	Depuy, Inc.
K982494	BWM SPINE SYSTEM	Sep 08, 1998	Substantially Equivalent	Howmedica Corp.
K982908	MODIFICATION TO EBI SPINELINK SYSTEM	Aug 28, 1998	Substantially Equivalent	Electro-Biology, Inc.
K982011	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM	Aug 06, 1998	Substantially Equivalent	DePuy Orthopaedics, Inc.
K980288	SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM	Jul 29, 1998	Substantially Equivalent for Some Indications	Spine-Tech, Inc.
K980121	AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS	Jun 10, 1998	Substantially Equivalent	Aesculap, Inc.
K981452	OSTEONICS LONG ARM CONTAINMENT RING	May 20, 1998	Substantially Equivalent	Osteonics Corp.
K980928	SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM	May 11, 1998	Substantially Equivalent	Synthes Spine
K980358	SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM	Apr 16, 1998	Substantially Equivalent	Synthes (Usa)
K974573	DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM	Feb 18, 1998	Substantially Equivalent for Some Indications	Depuy, Inc.
K973868	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	Jan 08, 1998	Substantially Equivalent for Some Indications	Osteotech, Inc.
K964159	CD SPINAL SYSTEM	Oct 16, 1997	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K965221	RANSFORD CERVICAL FIXATION SYSTEM	Aug 07, 1997	Substantially Equivalent	Surgicraft , Ltd.
K971457	BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED	Jul 16, 1997	Substantially Equivalent	Arcan Orthopaedic Corp.
K971289	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	Jun 18, 1997	Substantially Equivalent	Osteotech, Inc.
K965224	EMPOWER ANTERIOR DIRECT SCREWS	May 08, 1997	Substantially Equivalent	Smith & Nephew Richards, Inc.
K964254	TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM	Apr 21, 1997	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K964404	BACFIX SPINAL FIXATION SYSTEM	Mar 26, 1997	Substantially Equivalent for Some Indications	Spinal Concepts, Inc.
K964024	DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM	Mar 26, 1997	Substantially Equivalent	Depuy, Inc.
K962628	MOSS MIAMI SPINAL SYSTEM	Mar 18, 1997	Substantially Equivalent for Some Indications	Depuy, Inc.
K965145	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM	Mar 13, 1997	Substantially Equivalent	Depuy, Inc.
K962708	TITANIUM CD HORIZON SPINAL SYSTEM	Feb 06, 1997	Substantially Equivalent	Sofamor Danek USA,Inc.
K960444	FINN ROD TO ROD CONNECTOR	Jan 24, 1997	Substantially Equivalent	Smith & Nephew Richards, Inc.
K964275	ALPHA POSTERIOR SPINAL SYSTEM	Jan 14, 1997	Substantially Equivalent	Sofamor Danek USA,Inc.
K962314	HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM	Dec 09, 1996	Substantially Equivalent	Osteonics Corp.
K961633	CD HORIZON SPINAL SYSTEM	Dec 05, 1996	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K962984	ISOLA PEDIATRIC COMPONENTS	Nov 27, 1996	Substantially Equivalent for Some Indications	Acromed Corp.
K963639	ACROMED PEDICLE SCREW	Nov 14, 1996	Substantially Equivalent for Some Indications	Acromed Corp.
K955807	COTREL-DUBOUSSET (CD) SPINAL	Oct 01, 1996	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K955365	COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM	Mar 27, 1996	Substantially Equivalent	Sofamor Danek USA,Inc.
K955864	J.B. S. C1-C2 CLAMP	Mar 15, 1996	Substantially Equivalent	J.B.S., S.A.
K955927	BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)	Mar 13, 1996	Substantially Equivalent for Some Indications	Arcan Orthopaedic Corp.
K954696	ROGOZINSKI THORACOLUMBAR SPINAL ROD	Mar 11, 1996	Substantially Equivalent for Some Indications	Smith & Nephew Richards, Inc.
K955348	TITANIUM MOSS MIAMI SPINAL SYSTEM	Feb 16, 1996	Substantially Equivalent for Some Indications	Depuy, Inc.
K951846	MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS	Feb 14, 1996	Substantially Equivalent for Some Indications	Alphatec Mfg., Inc.
K955173	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	Feb 09, 1996	Substantially Equivalent for Some Indications	Osteotech, Inc.
K951164	CD LIBERTY POSTERIOR SPINCAL SYSTEM	Feb 09, 1996	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K954770	CENTRA-LINE GRAPPLE, VARIFIX SYSTEM	Jan 25, 1996	Substantially Equivalent	Advanced Spine Fixation Systems, Inc.
K954645	TITANIUM GDLH POSTERIOR SPINAL SYSTEM	Jan 16, 1996	Substantially Equivalent for Some Indications	Sofamor Danek USA,Inc.
K953599	CLAMP ASSEMBLY	Dec 19, 1995	Substantially Equivalent for Some Indications	J.B.S., S.A.
K936294	SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS	Dec 19, 1995	Substantially Equivalent for Some Indications	Sofamor Danek Mfg., Inc.
K942432	J.B.S. CERVICAL SPINE SYSTEM	Jul 11, 1995	Substantially Equivalent for Some Indications	J.B.S., S.A.
K945781	WEBB-MORLEY SPINE SYSTEM	Jun 22, 1995	Substantially Equivalent	Electro-Biology, Inc.
K945435	BRYAN POSTERIOR SPINAL FIXATOR (BPSF)	May 31, 1995	Substantially Equivalent	Arcan Orthopaedic Corp.
K945022	APOFIX CERVICAL SPINE FIXATION	May 15, 1995	Substantially Equivalent for Some Indications	Sofamor Co.
K931381	AME UNIVERSAL FIXATION SYSTEM	Feb 01, 1995	Substantially Equivalent for Some Indications	American Medical Electronics, Inc.
K935113	J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE	Oct 19, 1994	Substantially Equivalent	J.B.S., S.A.
K930009	STRYKER 2S SPINAL SYSTEM	Sep 01, 1994	Substantially Equivalent	Stryker Corp.
K933881	DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM	Jul 12, 1994	Substantially Equivalent	Depuy, Inc.
K930657	D-C-S SYSTEM	Jun 29, 1994	Unknown	Pina-Vertriebs
K930515	ALPHA SPINAL SYSTEM	Jun 29, 1994	Unknown	Alphatec Mfg., Inc.
K934582	GDLH VARIABLE ANGLE CONNECTOR	Jun 21, 1994	Substantially Equivalent for Some Indications	Danek Group, Inc.
K934860	TI-FRAME	Jun 03, 1994	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K934007	SOFAMOR ORFIL SPINE FIXATION SYSTEM	Jun 02, 1994	Substantially Equivalent	Sofamor Co.
K933205	TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON	May 04, 1994	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K931225	LOW PROFILE MID CROSS BRACING	May 02, 1994	Substantially Equivalent for Some Indications	Advanced Spine Fixation Systems, Inc.
K930891	SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST	Apr 29, 1994	Substantially Equivalent for Some Indications	Synthes (Usa)
K931208	LOW PROFILE SLEAVE NUT ASSEMBLY	Mar 28, 1994	Substantially Equivalent for Some Indications	Advanced Spine Fixation Systems, Inc.
K914548	BRYAN SPINAL FIXATER (BSF)	Mar 28, 1994	Substantially Equivalent for Some Indications	Arcan Orthopaedic Corp.
K930531	AME(R) RIGID FIXATION SYSTEM	Feb 01, 1994	Substantially Equivalent	American Medical Electronics, Inc.
K930710	SENTRY POSTERIOR SPINAL SYSTEM	Oct 01, 1993	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K924474	SELBY INSTRUMENTATION	Sep 21, 1993	Substantially Equivalent	Advanced Spine Fixation Systems, Inc.
K921056	COTREL - DUBOUSSET SPINE IMPLANTS	Jun 24, 1993	Substantially Equivalent	Buckman Co., Inc.
K921948	SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST	Jun 22, 1993	Substantially Equivalent	Synthes (Usa)
K921767	COMPACT COTREL -- DUBOUSSET SPINE SYSTEM	Jun 22, 1993	Substantially Equivalent	Buckman Co., Inc.
K924142	CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT	Jun 15, 1993	Substantially Equivalent	Codman & Shurtleff, Inc.
K915672	EDWARDS ADJUSTABLE CONNECTORS	May 26, 1993	Substantially Equivalent for Some Indications	Scientific Spinal , Ltd.
K925811	TSRH CENTRAL POST HOOKS	May 18, 1993	Substantially Equivalent for Some Indications	Sofamor Danek Mfg., Inc.
K924381	PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS	May 18, 1993	Substantially Equivalent for Some Indications	Cross Medical Products, Inc.
K922672	AUGMENT POSTERIOR SPINAL FIXATION SYSTEM	May 18, 1993	Substantially Equivalent for Some Indications	Sofamor Danek Mfg., Inc.
K922504	ISOLA(R) TANDEM CONNECTOR	May 18, 1993	Substantially Equivalent for Some Indications	Acromed Corp.
K921256	LUQUE V SPINAL SYSTEM	May 18, 1993	Substantially Equivalent for Some Indications	Sofamor Danek Mfg., Inc.
K920546	PARAGON POSTERIOR SPINAL SYSTEM	Jan 21, 1993	Substantially Equivalent for Some Indications	Sofamor Danek Mfg., Inc.
K921090	ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR	Dec 31, 1992	Substantially Equivalent	Acromed Corp.
K920392	ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION	Dec 31, 1992	Substantially Equivalent	Acromed Corp.
K922238	LEAPLAZA FRAME	Dec 23, 1992	Substantially Equivalent	Spintech, Inc.
K922520	MODIFIED TSRH CENTRAL POST HOOKS	Nov 16, 1992	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K923339	TSRH L CONNECTOR -- MODIFICATION	Oct 27, 1992	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K912837	MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS	Aug 26, 1992	Substantially Equivalent	Kirschner Medical Corp.
K914306	TSRH(TM) LATERAL OFFSET PLATE	Jun 19, 1992	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K914966	TSRH CENTRAL POST HOOKS	May 12, 1992	Substantially Equivalent	Sofamor Danek Mfg., Inc.
K920102	THE SELBY SYSTEM	May 05, 1992	Substantially Equivalent	Advanced Spine Fixation Systems, Inc.
K920116	PWB LUMBOSACRAL SPINE SYSTEM	Apr 10, 1992	Substantially Equivalent for Some Indications	Cross Medical Products, Inc.
K911663	CROSSLINK SYSTEM	Mar 23, 1992	Substantially Equivalent	Synthes (Usa)
K904243	TSRH VARIABLE ANGLE SACRAL SCREW	Jan 22, 1992	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K913561	LUQUE SEGMENTAL SPINAL INSTRUMENTATION	Jan 16, 1992	Substantially Equivalent	Zimmer, Inc.
K914269	EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO	Dec 18, 1991	Substantially Equivalent	Scientific Spinal , Ltd.
K904520	RAY SACRAL FIXATION SYSTEM	Oct 25, 1991	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K911307	CROSSLINK PLATE	Oct 24, 1991	Substantially Equivalent	Danek Medical, Inc.
K911379	DANEK SACRAL HOOK, MODIFICATION	Sep 11, 1991	Substantially Equivalent	Danek Medical, Inc.
K911319	TSRH OPEN HEAD BONE SCREW	Sep 06, 1991	Substantially Equivalent	Danek Medical, Inc.
K911528	ISOLA(TM) SPINE SYSTEM - ILIAC SCREW	Jun 28, 1991	Substantially Equivalent for Some Indications	Acromed Corp.
K911394	ISOLA(TM) SPINE SYSTEM--EYE ROD	Jun 21, 1991	Substantially Equivalent	Acromed Corp.
K905826	ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR	Mar 21, 1991	Substantially Equivalent	Acromed Corp.
K905184	ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK	Feb 15, 1991	Substantially Equivalent for Some Indications	Acromed Corp.
K903376	ACROMED SACRAL SCREW	Dec 27, 1990	Substantially Equivalent for Some Indications	Acromed Corp.
K902775	KNIGHT SACRAL SCREW	Dec 10, 1990	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K901005	TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)	Dec 10, 1990	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K903461	TSRH OFFSET AND SIDE-LOADING HOOKS	Dec 05, 1990	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K902397	MODULOCK POSTERIOR SPINAL FIXATION	Nov 05, 1990	Substantially Equivalent for Some Indications	Zimmer, Inc.
K901587	TSRH SACRAL L-CONNECTOR	Nov 05, 1990	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K901590	DANEK SACRAL HOOK	Aug 21, 1990	Substantially Equivalent for Some Indications	Danek Medical, Inc.
K895978	CHIBA SPINAL SYSTEM	Aug 09, 1990	Substantially Equivalent	Danek Medical, Inc.
K896106	ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS	Jun 25, 1990	Substantially Equivalent for Some Indications	Richards Medical Co., Inc.
K896254	DANEK PRECISION ROD SET	Jun 14, 1990	Substantially Equivalent	Danek Medical, Inc.
K895296	SELBY II INSTRUMENTATION	Mar 20, 1990	Substantially Equivalent for Some Indications	Advanced Spine Fixation
K896740	AXIAL AND OFFSET CROSSLINK PLATES	Feb 26, 1990	Substantially Equivalent	Danek Medical, Inc.
K896603	HSC UNIT ROD	Jan 30, 1990	Substantially Equivalent	Danek Medical, Inc.
K890192	LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET	Jan 04, 1990	Substantially Equivalent	Danek Medical, Inc.
K895441	ACROMED BUTTON SPINAL WIRE	Nov 22, 1989	Substantially Equivalent	Acromed Corp.
K895439	ACROMED BEADED SUBLAMINAR WIRE	Nov 22, 1989	Substantially Equivalent	Acromed Corp.
K895413	ACROMED DOUBLE SUBLAMINAR WIRE	Nov 22, 1989	Substantially Equivalent	Acromed Corp.
K894702	STUART CD UNIVERSAL ROD CONNECTOR CLAMPS	Oct 11, 1989	Substantially Equivalent for Some Indications	Bio-Medical Prosthetics
K894472	CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL	Oct 10, 1989	Substantially Equivalent	Buckman Co., Inc.
K884998	SELBY INSTRUMENTATION	Jun 22, 1989	Substantially Equivalent for Some Indications	Advanced Spine Fixation Systems, Inc.
K884690	KIRSCHNER SPINAL FIXATOR KMS-1	Jun 02, 1989	Substantially Equivalent for Some Indications	Kirschner Medical Corp.
K884161	ACROMED ILIAC SCREW	May 03, 1989	Substantially Equivalent for Some Indications	Buckman Co., Inc.
K884163	ACROMED SPINAL ROD AND SPINAL HOOKS	Apr 26, 1989	Substantially Equivalent	Buckman Co., Inc.
K890187	THE C-S DISTRACTION ROD ASSEMBLY	Apr 06, 1989	Substantially Equivalent	Orthopedic Systems, Inc.
K883783	TSRH SACRAL SPINAL SCREW	Apr 06, 1989	Substantially Equivalent for Some Indications	Warsaw Orthopedic, Inc.
K884688	MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD	Feb 24, 1989	Substantially Equivalent for Some Indications	Synthes (Usa)
K884585	LEA PLAZA SPINAL FRAME SYSTEM	Jan 27, 1989	Substantially Equivalent	Orthomet, Inc.
K884263	ROGOZINSKI SPINAL SYSTEM	Dec 29, 1988	Substantially Equivalent	Richards Medical Co., Inc.
K882070	LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS	Jun 03, 1988	Substantially Equivalent	Karlin Technology, Inc.
K882068	COBB SPINAL ELEVATORS	Jun 03, 1988	Substantially Equivalent	Karlin Technology, Inc.
K880212	TSRH H/M HOOK HOLDER W/ROD MOVER	Mar 04, 1988	Substantially Equivalent	Warsaw Orthopedic, Inc.
K880211	TSRH H/M HOOK HOLDER	Mar 04, 1988	Substantially Equivalent	Warsaw Orthopedic, Inc.
K875290	LUMBAR IMPACTION SET	Mar 04, 1988	Substantially Equivalent	T. Korossurgical Instruments Corp.
K880215	TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD	Feb 18, 1988	Substantially Equivalent	Warsaw Orthopedic, Inc.
K880214	TSRH H/M TORQUE LIMITING WRENCH	Feb 18, 1988	Substantially Equivalent	Warsaw Orthopedic, Inc.
K874882	ACROMED CROSS ROD CONNECTOR	Feb 18, 1988	Substantially Equivalent	Acromed Corp.
K871870	HSC UNIT ROD	Jul 21, 1987	Substantially Equivalent	Research Development Corp.
K870085	ANTERIOR SPINAL FIXATION PLATE	Jun 30, 1987	Substantially Equivalent	Terray Manufacturing, Inc.
K870830	WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM	May 04, 1987	Substantially Equivalent	Warsaw Orthopedic, Inc.
K854770	MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM	Feb 11, 1986	Substantially Equivalent	Advanced Biosearch Assn.
K854524	KIRSCHNER SPINAL PRODUCT SYSTEM	Dec 09, 1985	Substantially Equivalent	Kirschner Medical Corp.
K854313	SONGER TITANIUM SPINE-L-ROD	Nov 15, 1985	Substantially Equivalent	Ortho-Engineering Products Co.
K851935	EDWARDS SACRAL SCREW	Jun 07, 1985	Substantially Equivalent	Zimmer, Inc.
K850039	HALIFAX SPINAL CLAMP	May 29, 1985	Substantially Equivalent	Levtech, Inc.
K843445	SACRAL BAR	Feb 13, 1985	Substantially Equivalent	Stuart
K843687	ROD FOR RACHIS SURGERY	Jan 10, 1985	Substantially Equivalent	Sofamor Co.
K840423	HARRINGTON-TYPE INSTRU-SCOLIOSIS	Mar 23, 1984	Substantially Equivalent	Link America, Inc.
K820660	A HOOK DRIVER	Mar 19, 1982	Substantially Equivalent	Twin City Surgical, Inc.
K810329	DEPUY SEGMENTALSPINAL SYSTEM	Apr 08, 1981	Substantially Equivalent	Depuy, Inc.
K810224	ARMSTRONG SPINAL APPLIANCE	Feb 10, 1981	Substantially Equivalent	Howmedica Corp.
K802462	SYNTHES SPINAL IMPLANT SYSTEM	Dec 16, 1980	Substantially Equivalent	Synthes (Usa)
K801120	DUNN ANTERIOR DISTRACTION SYSTEM	May 20, 1980	Substantially Equivalent	Zimmer, Inc.
K801080	EDWARDS ROD SLEEVES	May 20, 1980	Substantially Equivalent	Zimmer, Inc.
K791009	SANTA CASA DISTRACTOR	Jun 11, 1979	Substantially Equivalent	Depuy, Inc.
K790465	KNEE COMPRESSION HOOK SYSTEM	Apr 12, 1979	Substantially Equivalent	Zimmer, Inc.
K790238	TRANSVERSE TRACTION ASSEMBLY	Feb 12, 1979	Substantially Equivalent	Zimmer, Inc.
K781444	OUTRIGGER DISTRACTION UNIT	Sep 27, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K781443	HARRINGTON SPINE INSTRUMENTATION	Sep 27, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.