Secure-Loop 35 mm 102-4035
by Xiros Ltd
Secure-Loop 35 mm 102-4035 is a Class II device made by Xiros Ltd, cleared under FDA 510(k) K151601 on 9 Sep 2015 and listed in FDA GUDID since 28 May 2017 (UDI-DI 05060267131461), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060267131461 | Date28 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151601 | Date9 Sep 2015 | StatusActive |
Official records
- AccessGUDID record 05060267131461
- FDA 510(k) database K151601
Across registries
- FDA 510(k) K151601 decided 9 Sep 2015 Active
- FDA GUDID UDI-DI 05060267131461 listed 28 May 2017 Listed
Timeline
- Cleared FDA 510(k) K151601
- Listed FDA GUDID 05060267131461
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Secure-Loop 35 mm
- Generic name
- Tendon/ligament bone anchor, non-bioabsorbable
- Model / Ref / Catalog
- 102-4035
- Primary DI / UDI-DI
- 05060267131461
- 510(k) Number
- FDA product code
- MBI
- GMDN term
- Tendon/ligament bone anchor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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