510(k) K071667 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SYNTHES VECTRA-ONE SYSTEM
| Applicant | Synthes Spine, West Chester PA, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Jun 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071667
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2014 | Synthes, Inc. DePuy Synthes TI Vectra Plates:
TI Vectra-One" Plate 2 Level / 34 mm
part 04.613.184
3337672
TI Vectra" Plate 3 Level / 57 mm
part 04.613.257
lot 3693878
TI Vectra" Plate 4 Level / 64 mm
part Terminated |
KWQ | None listed |
| Feb 4, 2013 | Synthes USA HQ, Inc. Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011.
Synthes Vectra System, Terminated |
KWQ | None listed |
| Feb 4, 2013 | Synthes USA HQ, Inc. Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012.
Synthes Vectra System, Synthes Vectra-One System and Synth Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.