510(k) K061345 ยท HRX Arthroscope
MODIFICATION TO ENDIUS ATAVI SYSTEM
| Applicant | Endius, Inc., Plainville MA, US |
| Decision | Substantially Equivalent, Jun 6, 2006 |
| Received | May 15, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2013 | Zimmer, Inc. Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070, N1830R80-060, N1830R50-100, N1830R50-090, N Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.