510(k) K000536 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SYNTHES ANTERIOR CSLP SYSTEM
| Applicant | Synthes Spine, Paoli PA, US |
| Decision | Substantially Equivalent, Mar 15, 2000 |
| Received | Feb 16, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000536
| 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.