Betta Link Knotless Implant System
FDA 510(k) clearance K210498 · decided 2021-03-24
Clearance details
- K-number
- K210498
- Device name
- Betta Link Knotless Implant System
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-22
- Decision date
- 2021-03-24
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gaaton, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the recall (Z-2060-2023) | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | 2023-07-03 |