Product Code: OWI


Products Classified as OWI

4674Bone Fixation Cerclage, SublaminarBone Fixation Cerclage.

Total Product Life Cycle (TPLC) Devices

4674Bone Fixation Cerclage, SublaminarBone Fixation Cerclage.

FDA Consensus Standards

Bone Fixation Cerclage, Sublaminar [37815]21 CFR §888.3010 šŸ”Ž
Bone Fixation Cerclage, Sublaminar [37434]21 CFR §888.3010 šŸ”Ž

Pre-market Notifications for OWI

K211057LigaPASSĀ® Spinal System, CD Horizonā„¢ Spinal SystemMedtronic, Inc.
K201240Mariner Cap SystemSeaSpine Orthopedics Corporation
K200281The Gecko Spinal SystemOrtho Development Corporation
K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.
K191217JAZZ PFImplanet, S.A.
K190418NuVasiveĀ® VersaTieĀ® SystemNuVasive, Incorporated
K190289KarmaĀ® Fixation SystemSpinal Elements Inc
K181799ResCUBEā„¢ Ligament Fixation SystemCousin Biotech S.A.S.
K180728Spinal Elements Cerclage SystemSpinal Elements Inc
K173506LigaPASSMedicrea International S.A.
K173117NuVasiveĀ® VersaTieā„¢ SystemNuVasive, Inc.
K172417SILCĀ® Fixation SystemGlobus Medical Inc.
K172206NAJAā„¢ Ligament Correction SystemCousin Biotech S.A.S.
K172021LigaPASSMedicrea International S.A.
K171881JAZZ Passer BandImplanet, S.A.

Global Unique Device Identification Database

00643169742949Bone fixation cerclage, sublaminar
00643169726932Bone fixation cerclage, sublaminar
00643169726925Bone fixation cerclage, sublaminar
00643169726918Bone fixation cerclage, sublaminar
00763000108397Bone fixation cerclage, sublaminar
00763000108380Bone fixation cerclage, sublaminar
03607505503516Bone Fixation Cerclage, Sublaminar
03607505503509Bone Fixation Cerclage, Sublaminar
03607505500621Bone Fixation Cerclage, Sublaminar
03607503502603Bone Fixation Cerclage, Sublaminar
03607503502580Bone Fixation Cerclage, Sublaminar
03607503502566Bone Fixation Cerclage, Sublaminar
03607503501576Bone Fixation Cerclage, Sublaminar
03607505504025Bone Fixation Cerclage, Sublaminar
03607505504018Bone Fixation Cerclage, Sublaminar

Maude Adverse Events

JAZZIMPLANET2020-03-19
RESPONSE BANDLOC SPINAL FIXATIONORTHOPEDIATRICS, CORP2020-02-10
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-12-06
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-12-06
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-12-06
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-08
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-08
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-08
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-10-23
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-10-23
NUVASIVE? VERSATIE SYSTEMNUVASIVE INC.2019-04-25
NILE ALTERNATIVE FIXATION SYSTEM SYSTEMK2M. INC2019-04-24
TRANSLACE SPINAL TETHERING SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-04-19
NILE ? ALTERNATIVE FIXATION SYSTEMK2M. INC2019-01-22
SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MMZIMMER SPINE2019-01-08
SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MMZIMMER SPINE2019-01-08
SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MMZIMMER SPINE2018-08-07
SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MMZIMMER SPINE2018-08-07
JAZZ LOCKIMPLANET2017-11-24
NUVASIVE? VERSATIE SYSTEMNUVASIVE, INC.2017-11-07
NILE ALTERNATIVE FIXATION SPINAL SYSTEMK2M INC.2017-10-27
JAZZ SYSTEMSIMPLANET2017-06-12
SILCGLOBUS MEDICAL, INC.2017-05-10
JAZZIMPLANET2017-02-07
UNIVERSAL CLAMP ?5.5 MM TIZIMMER SPINE2016-12-16
NILE ALTERNATIVE FIXATION SPINAL SYSTEMK2M, INC.2016-11-18
NILE ALTERNATIVE FIXATION SYSTEMK2M, INC.2016-11-15
NILE ALTERNATIVE FIXATION SYSTEMK2M, INC.2016-11-15
UNIVERSAL CLAMP, 5.5MM TIILEZIMMER SPINE2016-10-12
NILE ALTERNATIVE FIXATIONK2M, INC.2016-04-06
NILE ALTERNATIVE FIXATIONK2M, INC.2015-11-24
UNIVERSAL CLAMP GENERICZIMMER SPINE2014-10-31
Ā© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.