510(k) K061147 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 30, 2006 |
| Received | Apr 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Innovasis, Inc Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag.
Product Usage:
4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. T Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.