The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for Betta Link Knotless Implant System.
| Device ID | K210498 |
| 510k Number | K210498 |
| Device Name: | Betta Link Knotless Implant System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Contact | Shlomi Dines |
| Correspondent | Anat Rozen T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-22 |
| Decision Date | 2021-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818674025796 | K210498 | 000 |
| 10818674025789 | K210498 | 000 |
| 10818674025772 | K210498 | 000 |
| 10818674025765 | K210498 | 000 |