Identity
- Trade Name
- SOLAR FDA UDI
- Generic Name
- Coated elbow humerus prosthesis FDA UDI
- Device Name
- Elbow Humeral Component FDA UDI
- Model / Reference
- 5005-013R FDA UDI
- Description
- Elbow Humeral Component FDA UDI
Identifiers
- Catalog Number
- 5005-013R FDA UDI
- Primary DI / UDI-DI
- 07613327137705 FDA UDI
- 510(k) Number
- K980502 FDA UDI
- FDA Product Code
- JDC FDA UDI
- GMDN Term
- Coated 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coated elbow humerus prosthesis
Solar by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated elbow humerus prosthesis.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DISCOVERY ELBOW SYSTEM — Biomet Orthopedics, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- LATITUDE EV™ — TORNIER, 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 d4b7b6cc-f1a7-4f40-a5dc-372382288131 36 fields · synced May 31, 2026