Product Code: OWI FDA class 2 21 CFR 888.3010

Bone Fixation Cerclage, Sublaminar

Orthopedic

The Bone Fixation Cerclage, Sublaminar is an orthopedic implant that acts as a bone anchor for temporary stabilization or used in conjunction with other metallic medical implants when wiring is needed during development of a spinal fusion. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWI, with regulation number 888.3010 under the Orthopedic specialty, and it carries an implant flag indicating it is placed within the body.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OWI
Device Class: FDA class 2
Regulation Number: 888.3010
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261374	LigaPASS System	May 27, 2026	Substantially Equivalent	Medicrea International S.A.S
K253615	Invictus Bands System	Mar 25, 2026	Substantially Equivalent	Alphatec Spine, Inc.
K222097	OLYMPIC Deformity Band System	May 04, 2023	Substantially Equivalent	Astura Medical
K230565	HILINE Fixation System	Apr 20, 2023	Substantially Equivalent	Globus Medical, Inc.
K213659	LigaPASS 2.0 Ligament Augmentation System	May 24, 2022	Substantially Equivalent	Medicrea International SA
K211057	LigaPASS® Spinal System, CD Horizon Spinal System	May 27, 2021	Substantially Equivalent	Medtronic, Inc.
K201240	Mariner Cap System	Aug 05, 2020	Substantially Equivalent	SeaSpine Orthopedics Corporation
K200281	The Gecko Spinal System	Mar 31, 2020	Substantially Equivalent	Ortho Development Corporation
K200097	Response BandLoc Spinal Fixation	Mar 16, 2020	Substantially Equivalent	OrthoPediatrics Corp.
K191217	JAZZ PF	Aug 02, 2019	Substantially Equivalent	Implanet, S.A.
K190289	Karma® Fixation System	Apr 03, 2019	Substantially Equivalent	Spinal Elements, Inc.
K190418	NuVasive® VersaTie® System	Mar 21, 2019	Substantially Equivalent	Nu Vasive, Incorporated
K180728	Spinal Elements Cerclage System	Sep 06, 2018	Substantially Equivalent	Spinal Elements, Inc.
K181799	ResCUBE Ligament Fixation System	Aug 29, 2018	Substantially Equivalent	Cousin Biotech Sas
K172206	NAJA Ligament Correction System	Apr 10, 2018	Substantially Equivalent	Cousin Biotech Sas
K173506	LigaPASS	Apr 03, 2018	Substantially Equivalent	Medicrea International SA
K173117	NuVasive® VersaTie System	Dec 07, 2017	Substantially Equivalent	Nuvasive, Inc.
K172417	SILC® Fixation System	Oct 26, 2017	Substantially Equivalent	Globus Medical, Inc.
K172021	LigaPASS	Aug 30, 2017	Substantially Equivalent	Medicrea International SA
K171881	JAZZ Passer Band	Aug 08, 2017	Substantially Equivalent	Implanet, S.A.
K170730	JAZZ System, including JAZZ Band	Jun 09, 2017	Substantially Equivalent	Implanet, S.A.
K163181	TRANSLACE Spinal Tethering System	May 16, 2017	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K161332	NILE Proximal Fixation Spinal System	Apr 05, 2017	Substantially Equivalent	K2m, Inc.
K160698	LigaPASS	Sep 02, 2016	Substantially Equivalent	Medicrea International SA
K161267	Response BandLoc Spinal Fixation	Aug 11, 2016	Substantially Equivalent	OrthoPediatrics Corp.
K161265	NuVasive® VersaTie System	Jul 15, 2016	Substantially Equivalent	Nu Vasive, Incorporated
K153348	JAZZ LOCK	Mar 31, 2016	Substantially Equivalent	Implanet, S.A.
K160208	NILE Alternative Fixation Spinal System	Mar 18, 2016	Substantially Equivalent	K2m, Inc.
K151740	JAZZ System	Aug 27, 2015	Substantially Equivalent	Implanet, S.A.
K143759	JAZZ System	May 07, 2015	Substantially Equivalent	Implanet, S.A.
K143350	Nile Alternative Fixation	Feb 25, 2015	Substantially Equivalent	K2m, Inc.
K142053	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	Oct 29, 2014	Substantially Equivalent	Zimmer Spine, Inc.
K133482	SILC FIXATION SYSTEM	May 21, 2014	Substantially Equivalent	Globus Medical, Inc.
K133617	JAZZ SYSTEM	Feb 20, 2014	Substantially Equivalent	Implanet, S.A.
K132395	LIGAPASS	Dec 06, 2013	Substantially Equivalent	Medicrea International
K132287	JAZZ SYSTEM	Sep 25, 2013	Substantially Equivalent	Hogan Lovells US LLP
K110348	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	Aug 11, 2011	Substantially Equivalent	Zimmer Spine