510(k) K101100 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
| Applicant | Conmed Linvatec, Largo FL, US |
| Decision | Substantially Equivalent, Aug 26, 2010 |
| Received | Apr 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | ConMed Corporation CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable
Driver
REF# CFBC-5502B
5.5mm GENESYs CrossFT Suture Anchor with
two, #2 (5 metric) Hi-Fi Sutures
Sterile Open, Classified |
MAI | None listed |
| Jul 1, 2013 | Linvatec Corp. dba ConMed Linvatec GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502.
Reattachment of soft tissue to bone in orthopedic surgical Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.