Identity
- Trade Name
- COMPREHENSIVE® SRS / NEXEL FDA UDI
- Generic Name
- Uncoated elbow humerus prosthesis FDA UDI
- Model / Reference
- 110029938 FDA UDI
Identifiers
- Catalog Number
- 110029938 FDA UDI
- Primary DI / UDI-DI
- 00880304806030 FDA UDI
- 510(k) Number
- K153398 FDA UDI
- FDA Product Code
- KWS FDA UDIMBF FDA UDIKWT FDA UDIJDC FDA UDI
- GMDN Term
- Uncoated elbow humerus prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3650 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Uncoated elbow humerus prosthesis
Comprehensive® Srs / Nexel by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated elbow humerus prosthesis.
- TEMA Elbow — Limacorporate · Class II
- Total Elbow — Howmedica Osteonics Corp. · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class II
Cleared under the same submission
K153398 also covers:
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SRS / NEXEL — Biomet Orthopedics, Inc.
- Comprehensive® SRS — Biomet Orthopedics, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 8192c162-983c-4ad8-89ec-10aa9b2dab5a 36 fields · synced May 30, 2026