510(k) K090128 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
TAC-TITE (TM)
| Applicant | Core Essence Orthopaedics, Inc., Yardley PA, US |
| Decision | Substantially Equivalent, Mar 19, 2009 |
| Received | Jan 21, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090128
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.