510(k) K071498 ยท HWC Screw, Fixation, Bone
SUBTALAR IMPLANT
| Applicant | Biomet Sports Medicine, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 31, 2007 |
| Received | May 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displa Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 11 mm x 17 mm, REF 982365, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 12 mm x 18 mm, REF 982366, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | None listed |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.