Infinity-Lock Button System 102-1089
by Xiros Ltd
Infinity-Lock Button System 102-1089 is a Class II device made by Xiros Ltd, cleared under FDA 510(k) K180243 on 3 Apr 2018 and listed in FDA GUDID since 12 Aug 2019 (UDI-DI 05060267131836), 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 GUDID | Number05060267131836 | Date12 Aug 2019 | StatusListed |
| United States | FDA 510(k) 510(k) | NumberK180243 | Date3 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 05060267131836
- FDA 510(k) database K180243
Across registries
- FDA 510(k) K180243 decided 3 Apr 2018 Active
- FDA GUDID UDI-DI 05060267131836 listed 12 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K180243
- Listed FDA GUDID 05060267131836
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Infinity-Lock Button System
- Generic name
- Acromioclavicular joint stabilization implant
- Model / Ref / Catalog
- 102-1089
- Primary DI / UDI-DI
- 05060267131836
- 510(k) Number
- FDA product code
- HTN
- GMDN term
- Acromioclavicular joint stabilization implant
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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