510(k) K982497 ยท HWC Screw, Fixation, Bone
ARTHROTEK INTERFERENCE SCREW
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 16, 1998 |
| Received | Jul 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2018 | Zimmer Biomet, Inc. Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 Terminated |
HWC | None listed |
| Jul 20, 2018 | Zimmer Biomet, Inc. Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 Terminated |
HWC | None listed |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | None listed |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | None listed |
| Jul 1, 2015 | Biomet, Inc. Gentle Threads Interference Screw 9x35mm Full Thread.
An interference fixation screw for use in soft tissue reattachment procedures Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.