Identity
- Trade Name
- TraumaOne SYSTEM FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- 01-0298 FDA UDI
Identifiers
- Catalog Number
- 01-0298 FDA UDI
- Primary DI / UDI-DI
- 00888233024976 FDA UDI
- FDA Product Code
- DZL FDA UDIJEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI872.4760 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
MR Conditional FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
TraumaOne 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
K143336 also covers:
- OMNIMAX MMF SYSTEM — BIOMET MICROFIXATION, INC
- TRAUMAONE SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
K152326 also covers:
K202969 also covers:
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX MMF SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — 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 7fcb3973-865c-4981-9f1f-3f7404388a62 35 fields · synced May 31, 2026