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Infinity-Lock Button System
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K180243
by Xiros Ltd
Identity
- Trade Name
- Infinity-Lock Button System FDA UDI
- Generic Name
- Acromioclavicular joint stabilization implant FDA UDI
- Model / Reference
- 102-1089 FDA UDI
Identifiers
- Catalog Number
- n/a FDA UDI
- Primary DI / UDI-DI
- 05060267131836 FDA UDI
- 510(k) Number
- K180243 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Acromioclavicular joint stabilization implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cannulated surgical drill bit, single-useAcromioclavicular joint stabilization implant
Infinity-Lock Button System by Xiros Ltd — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180243 | Class II | Active |
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Manufacturer
- Manufacturer
- Xiros Ltd
- FDA Applicant
- Xiros, Ltd.
Sources (2)
- FDA UDI e49a480f-5077-4e2f-946a-800ec6d3bbff 59 fields · synced Jun 18, 2026
- FDA 510(k) K180243 1 fields · synced Jun 4, 2026