510(k) K981529 ยท JDS Nail, Fixation, Bone
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 9, 1998 |
| Received | Apr 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2013 | Smith & Nephew Inc INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod f Terminated |
JDS | None listed |
| Mar 13, 2013 | Smith & Nephew Inc INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod f Terminated |
JDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.