TekBrace Solo Soft Tissue Reinforcement Device
FDA 510(k) clearance K251063 · decided 2025-05-30
Clearance details
- K-number
- K251063
- Device name
- TekBrace Solo Soft Tissue Reinforcement Device
- Applicant
- Theramicro
- Decision
- Substantially Equivalent
- Date received
- 2025-04-04
- Decision date
- 2025-05-30
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- QUW
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cordova, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TekBrace Solo Soft Tissue Reinforcement Device (K261621) | Theramicro | 2026-06-09 |
| Jewel Soft Tissue Reinforcement Device (102-6005) (K242237) | Xiros Limited | 2025-07-15 |
| Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978) | Xiros, Ltd. | 2022-12-27 |
Recalls involving this device
No recalls on record reference this clearance.