Identity
- Trade Name
- 1.5MM SYSTEM FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- 01-8613 FDA UDI
Identifiers
- Catalog Number
- 01-8613 FDA UDI
- Primary DI / UDI-DI
- 00841036282219 FDA UDI
- 510(k) Number
- K121589 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
1.5mm System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121589 also covers:
- "1.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM PLATE — BIOMET MICROFIXATION, 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 Microfixation, Inc
Sources (1)
- FDA UDI c21d5826-118f-4320-b017-17428decf835 35 fields · synced May 30, 2026