510(k) K162429 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
ZipE Knotless Tissue Repair and Attachment Devices
| Applicant | Ziptek, LLC, Sarasota FL, US |
| Decision | Substantially Equivalent, Mar 13, 2017 |
| Received | Aug 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162429
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.