Identity
- Trade Name
- Total Elbow FDA UDI
- Generic Name
- Uncoated elbow humerus prosthesis FDA UDI
- Device Name
- Axle Pin FDA UDI
- Model / Reference
- 5003-1510 FDA UDI
- Description
- Axle Pin FDA UDI
Identifiers
- Catalog Number
- 5003-1510 FDA UDI
- Primary DI / UDI-DI
- 07613327013993 FDA UDI
- 510(k) Number
- K980502 FDA UDI
- FDA Product Code
- JDC FDA UDI
- GMDN Term
- Uncoated elbow humerus prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3150 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uncoated elbow humerus prosthesis
Total Elbow by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated elbow humerus prosthesis.
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
- Comprehensive® SRS / Discovery® — Biomet Orthopedics, Inc. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K980502 also covers:
- Axel Pin Assembly Standard Elbow — Howmedica Osteonics Corp.
- Bearing and Axle Bushing Assembly - Standard Elbow — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
- SOLAR — Howmedica Osteonics Corp.
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 4a6c6582-3d3e-4c6f-8922-5606fae78a96 36 fields · synced Jun 8, 2026