Identity
- Trade Name
- TRAUMAONE SYSTEM FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- SP-3000-PBR FDA UDI
Identifiers
- Catalog Number
- SP-3000-PBR FDA UDI
- Primary DI / UDI-DI
- 00841036168223 FDA UDI
- 510(k) Number
- K113512 FDA UDI
- FDA Product Code
- JEY FDA UDIHWC 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 UDI888.3040 FDA UDI
- Commercial Distribution
- Not 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
Traumaone System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113512 also covers:
- "2.4MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.4MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.4MM" SYSTEM — BIOMET MICROFIXATION, INC
- 2.0/1.5MM LOCKING FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 2.0/2.4MM FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM LOCKING FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM LOCKING FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM LOCKING FRACTURE SYSTEM — BIOMET MICROFIXATION, INC
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.4MM LOCKING RECON SYSTEM — BIOMET MICROFIXATION, INC
- 2.4MM SYSTEM — BIOMET MICROFIXATION, INC
- 2.4MM 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 f220b62a-75d0-4e16-ae97-ce60070365be 36 fields · synced Jun 8, 2026