510(k) K210498 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Betta Link Knotless Implant System
| Applicant | T.A.G. Medical Products Corporation, Ltd., Gaaton, IL |
| Decision | Substantially Equivalent, Mar 24, 2021 |
| Received | Feb 22, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number:110 Open, Classified |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.