510(k) K222978
- Device
- Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- Applicant
- Xiros, Ltd.
- 510(k) number
- K222978
- Product code
- QUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-27
- Date received
- 2022-09-28
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steve Curran
- Address
- Springfield House Ln., Whitehouse Ln. Leeds GB LS17 7UE LS17 7UE
FDA Registration Numbers#
- 1417592
- 3007663067
- 3032412536
- 3002807315
- 8044102
Source Documents#
Other 510(k) Records For Product Code QUW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-08-18 |
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-06-09 |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | 2025-07-15 |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025-05-30 |