510(k) K971883 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Oct 16, 1997 |
| Received | May 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2016 | Synthes (USA) Products LLC Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879 Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.