510(k) K921481 ยท HWC Screw, Fixation, Bone
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
| Applicant | Acufex Microsurgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Aug 24, 1993 |
| Received | Mar 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Smith & Nephew, Inc. CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014 Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.