510(k) K982953 ยท HSB Rod, Fixation, Intramedullary And Accessories
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 21, 1998 |
| Received | Aug 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. TI Screw Buttress Thread 5MM (D) x 35MM (L)
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. TI Screw Buttress Thread 6MM (D) x 65MM (L)
Trauma Fixation Systems, Rx Only;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | None listed |
| Sep 21, 2009 | EBI, L.P. Uniflex Ti Buttress Thread Screw;
TI Screw Buttress Thread
Trauma Fixation Systems, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
Intended to aid in the alignment and stabilization of f Terminated |
HSB | None listed |
| Jun 22, 2005 | EBI, L.P. Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640. Terminated |
HXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.