510(k) K964500 ยท HTY Pin, Fixation, Smooth
ACUMED TENSION BAND PIN
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Dec 9, 1996 |
| Received | Nov 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2014 | Acumed LLC The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. .
2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S
2.0 mm SS Sleeve Only; Part Number 01-0022-S
8, 7 hol Terminated |
HTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.