Identity
- Trade Name
- TRAUMAONE SYSTEM FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- SP-2330 FDA UDI
Identifiers
- Catalog Number
- SP-2330 FDA UDI
- Primary DI / UDI-DI
- 00841036133795 FDA UDI
- 510(k) Number
- K113512 FDA UDI
- FDA Product Code
- HWC FDA UDIJEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI872.4760 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 7a2945e2-156a-4eb7-94a8-18973daf2864 36 fields · synced May 31, 2026