510(k) K162153 · HWC Screw, Fixation, Bone
Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
| Applicant | Ascension Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent, Jul 14, 2017 |
| Received | Aug 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162153
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.