Identity
- Trade Name
- TraumaOne SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- SP-3236 FDA UDI
Identifiers
- Catalog Number
- SP-3236 FDA UDI
- Primary DI / UDI-DI
- 00888233018319 FDA UDI
- 510(k) Number
- K983728 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Orthopaedic bone screw, non-bioabsorbable, non-sterile
TraumaOne SYSTEM by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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Cleared under the same submission
K983728 also covers:
- 2.0MM SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION SYSTEM — BIOMET MICROFIXATION, INC
- INTERMAXILLARY FIXATION 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 98c2d84a-918f-442f-b834-d147148cf8a1 35 fields · synced May 30, 2026