510(k) K081770 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
BLACK WIDOW ANTERIOR BUTTRESS PLATE
| Applicant | Omni Surgical, L.P., Austin TX, US |
| Decision | Substantially Equivalent, Apr 2, 2009 |
| Received | Jun 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | Amendia, Inc Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123
The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of all Terminated |
KWQ | None listed |
| Dec 22, 2016 | Amendia, Inc Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030
The Black Widow Buttress Plates and Screws ar Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.