Identity
- Trade Name
- Affiniti FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- HUMERAL HEAD TRIAL SCREW FDA UDI
- Model / Reference
- 9000526 FDA UDI
- Description
- HUMERAL HEAD TRIAL SCREW FDA UDI
Identifiers
- Catalog Number
- 9000526 FDA UDI
- Primary DI / UDI-DI
- 00846832023493 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Affiniti by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI d30791f2-885d-446e-8698-4160a9a88fd0 37 fields · synced Jun 1, 2026