510(k) K143576 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Exactech Ambassador
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 27, 2015 |
| Received | Dec 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2015 | Exactech, Inc. Exactech Single Barrel Drill Guides
The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surge Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.