Identity
- Trade Name
- HLS UNI EVOLUTION FDA UDI
- Generic Name
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
- Model / Reference
- GDU142 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700386913297 FDA UDI
- 510(k) Number
- K022211 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hls Uni Evolution by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K022211 also covers:
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 086b5b69-9bff-44f5-bd9b-c6ff8b1adaf1 36 fields · synced May 30, 2026