510(k) K261621
- Device
- TekBrace Solo Soft Tissue Reinforcement Device
- Applicant
- Theramicro
- 510(k) number
- K261621
- Product code
- QUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-09
- Date received
- 2026-05-15
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christine Scifert
- Address
- 51 Germantown Ct. Suite 200 Cordova TN US 38018 38018
FDA Registration Numbers#
- 3032412536
- 8044102
- 3002807315
- 3007663067
- 1417592
Source Documents#
Other 510(k) Records For Product Code QUW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | 2025-07-15 |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025-05-30 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-12-27 |