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Panels › Orthopedic › Product code OWI · Class 2

Bone Fixation Cerclage, Sublaminar

Regulation 888.3010

2510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in OWI

Company510(k)sRecalls
Implanet, S.A.70
Medicrea International51
Globus Medical, Inc.30
K2m, Inc.30
OrthoPediatrics Corp.21
Cousin Biotech Sas20
Nu Vasive, Incorporated20
Spinal Elements, Inc.20
Zimmer Spine20
Alphatec Spine, Inc.10
Decided510(k)Device and applicantCode
May 27, 2026K261374LigaPASS™ System
Medicrea International S.A.S, FR
OWI
Mar 25, 2026K253615Invictus Bands System
Alphatec Spine, Inc.
OWI
May 4, 2023K222097OLYMPIC Deformity Band System
Astura Medical
OWI
Apr 20, 2023K230565HILINE™ Fixation System
Globus Medical, Inc.
OWI
May 24, 2022K213659LigaPASS™ 2.0 Ligament Augmentation System
Medicrea International SA, FR
OWI
May 27, 2021K211057LigaPASS® Spinal System, CD Horizon™ Spinal System
Medtronic, Inc.
OWI
Aug 5, 2020K201240Mariner Cap System
SeaSpine Orthopedics Corporation
OWI
Mar 31, 2020K200281The Gecko Spinal System
Ortho Development Corporation
OWI
Mar 16, 2020K200097Response BandLoc Spinal Fixation
OrthoPediatrics Corp.
OWI
Aug 2, 2019K191217JAZZ PF
Implanet, S.A., FR
OWI
Apr 3, 2019K190289Karma® Fixation System
Spinal Elements, Inc.
OWI
Mar 21, 2019K190418NuVasive® VersaTie® System
Nu Vasive, Incorporated
OWI
Sep 6, 2018K180728Spinal Elements Cerclage System
Spinal Elements, Inc.
OWI
Aug 29, 2018K181799ResCUBE™ Ligament Fixation System
Cousin Biotech Sas, FR
OWI
Apr 10, 2018K172206NAJA™ Ligament Correction System
Cousin Biotech Sas, FR
OWI
Apr 3, 2018K173506LigaPASS
Medicrea International SA, FR
OWI
Dec 7, 2017K173117NuVasive® VersaTie™ System
Nuvasive, Inc.
OWI
Oct 26, 2017K172417SILC® Fixation System
Globus Medical, Inc.
OWI
Aug 30, 2017K172021LigaPASS
Medicrea International SA, FR
OWI
Aug 8, 2017K171881JAZZ Passer Band
Implanet, S.A., FR
OWI
Jun 9, 2017K170730JAZZ System, including JAZZ Band
Implanet, S.A., FR
OWI
May 16, 2017K163181TRANSLACE™ Spinal Tethering System
Medtronic Sofamor Danek USA, Inc.
OWI
Apr 5, 2017K161332NILE Proximal Fixation Spinal System
K2m, Inc.
OWI
Sep 2, 2016K160698LigaPASS
Medicrea International SA, FR
OWI
Aug 11, 2016K161267Response BandLoc Spinal Fixation
OrthoPediatrics Corp.
OWI
Jul 15, 2016K161265NuVasive® VersaTie System
Nu Vasive, Incorporated
OWI
Mar 31, 2016K153348JAZZ LOCK
Implanet, S.A., FR
OWI
Mar 18, 2016K160208NILE Alternative Fixation Spinal System
K2m, Inc.
OWI
Aug 27, 2015K151740JAZZ System
Implanet, S.A., FR
OWI
May 7, 2015K143759JAZZ System
Implanet, S.A., FR
OWI
Feb 25, 2015K143350Nile Alternative Fixation
K2m, Inc.
OWI
Oct 29, 2014K142053UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Zimmer Spine, Inc.
OWI
May 21, 2014K133482SILC FIXATION SYSTEM
Globus Medical, Inc.
OWI
Feb 20, 2014K133617JAZZ SYSTEM
Implanet, S.A.
OWI
Dec 6, 2013K132395LIGAPASS
Medicrea International, FR
OWI
Sep 25, 2013K132287JAZZ SYSTEM
Hogan Lovells US LLP
OWI
Aug 11, 2011K110348UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Zimmer Spine
OWI

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