Identity
- Trade Name
- TEMA Elbow FDA UDI
- Generic Name
- Hinged total elbow prosthesis FDA UDI
- Device Name
- Axle Small FDA UDI
- Model / Reference
- 1590.15.010 FDA UDI
- Description
- Axle Small FDA UDI
Identifiers
- Catalog Number
- 1590.15.010 FDA UDI
- Primary DI / UDI-DI
- 08033390128865 FDA UDI
- FDA Product Code
- JDB FDA UDIJDC FDA UDI
- GMDN Term
- Hinged total elbow prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3160 FDA UDI888.3150 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
No
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
Category: Hinged total elbow prosthesis
TEMA Elbow by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hinged total elbow prosthesis.
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- Latitude™ - Elbow — TORNIER, INC. · Class II
- Latitude™ - Elbow — TORNIER, INC. · Class II
- Latitude™ - Elbow — TORNIER, INC. · Class II
- Latitude™ - Elbow — TORNIER, INC. · Class II
- Nexel" — Zimmer, Inc. · Class II
- Latitude™ - Elbow — TORNIER, INC. · Class II
- Latitude™ - Elbow — TORNIER, INC. · Class II
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
- Limacorporate
Sources (1)
- FDA UDI b70b6a54-a9b8-44ed-825c-76e2159fde87 35 fields · synced May 30, 2026