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Bone Fixation Cerclage, Sublaminar
FDA product code OWI · Class 2 · Orthopedic
353
Registered devices
68
Adverse events
2
Recalls
37
510(k) clearances
Devices with this code
JAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETMariner Cap — Seaspine Orthopedics CorporationResCUBE™ — COUSIN BIOTECHJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ LOCK — IMPLANETBandLoc DUO — ORTHOPEDIATRICS CORP.LIGAPASS — MEDICREA INTERNATIONALJAZZ System — IMPLANETMariner Cap — Seaspine Orthopedics CorporationNILE™ Alternative Fixation System — VB Spine LLCMariner Cap — Seaspine Orthopedics CorporationJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETJAZZ System — IMPLANETNILE™ Alternative Fixation System — VB Spine LLCJAZZ Lock — IMPLANET
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-08 | Medicrea International | Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of inf |
| 2017-04-24 | OrthoPediatrics Corp | Over-tensioning of the band resulting in damage to the band causing it to rupture |
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