510(k) K041274 ยท HWC Screw, Fixation, Bone
RESORBABLE INTERFERENCE SCREW
| Applicant | Arthrotek, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 28, 2004 |
| Received | May 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905604, 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. 905605, 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. 905607, 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. 905608, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | None listed |
| Jul 1, 2015 | Biomet, Inc. Gentle Threads Interference Screw 10x25mm Round Head.
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.