510(k) K984209 ยท HWC Screw, Fixation, Bone
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 3, 1999 |
| Received | Nov 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended t Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L);
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended t Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.