Identity
- Trade Name
- COMPREHENSIVE SRS INSTRUMENT FDA UDI
- Generic Name
- Humeral stem extension prosthesis trial FDA UDI
- Model / Reference
- 405111 FDA UDI
Identifiers
- Catalog Number
- 405111 FDA UDI
- Primary DI / UDI-DI
- 00880304542044 FDA UDI
- 510(k) Number
- K111746 FDA UDI
- FDA Product Code
- KWS FDA UDIMBF FDA UDIJDC FDA UDIKWT FDA UDI
- GMDN Term
- Humeral stem extension prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3150 FDA UDI888.3650 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Humeral stem extension prosthesis trial
Comprehensive Srs Instrument by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral stem extension prosthesis trial.
- Remedy Spacer — OSTEOREMEDIES, LLC · Class I
- TEMA Elbow — Limacorporate · Class I
- Remedy Spacer — OSTEOREMEDIES, LLC · Class I
- SMR Shoulder — Limacorporate · Class II
- TEMA Elbow — Limacorporate · Class I
- TEMA Elbow — Limacorporate · Class I
- SMR Shoulder — Limacorporate · Class II
- SMR Shoulder — Limacorporate · Class II
Cleared under the same submission
K111746 also covers:
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS HEX DRIVER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — 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 38cdbbd0-c442-4d5e-9178-4a8695690f1b 36 fields · synced May 30, 2026