510(k) K072161 ยท HSB Rod, Fixation, Intramedullary And Accessories
BIOMET FEMORAL LOCKING NAIL SYSTEM
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 20, 2007 |
| Received | Aug 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. TI Cann Partl Thd Recon Screw 6.00MM x 65MM;
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 Cann Partl Thd Recon Screw 6.00MM x 70MM;
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 Cann Partl Thd Recon Screw 6.00MM x 75MM;
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 Cann Partl Thd Recon Screw 6.00MM x 80MM;
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 Cann Partl Thd Recon Screw 6.00MM x 85MM;
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 Cann Partl Thd Recon Screw 6.00MM x 90MM;
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 Cann Partl Thd Recon Screw 6.00MM x 95MM;
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. Phoenix Cannulated Recon Screw;
Ti-Cann PARTL THD Recon Screw
Trauma Fixation Systems;
Rx only
Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054
Intended to aid in the alignment and stabili Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.