Identity
- Trade Name
- Comprehensive Mini Baseplate FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Model / Reference
- SSI001696 FDA UDI
Identifiers
- Catalog Number
- SSI001696 FDA UDI
- Primary DI / UDI-DI
- 00880304990135 FDA UDI
- 510(k) Number
- K120121 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 5 degree FDA UDI
Category: General external orthopaedic fixation system implantation kit, reusable
Comprehensive Mini Baseplate by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120121 also covers:
- 10 Deg 36mm Adj B-D Mini Sizer — Biomet Orthopedics, Inc.
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 713f1cd2-10ad-4888-8a38-cac59797c6de 36 fields · synced Jun 8, 2026