Identity
- Trade Name
- STERILE TRAC FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- 91-6105-W FDA UDI
Identifiers
- Catalog Number
- 91-6105-W FDA UDI
- Primary DI / UDI-DI
- 00841036085049 FDA UDI
- 510(k) Number
- K031751 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
A comprehensive medical device directory listing the STERILE TRAC, a crucial orthopedic screw for craniofacial bone fixation and reconstruction.
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Also classified as Craniofacial bone screw, non-bioabsorbable.
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Cleared under the same submission
K031751 also covers:
- 1.5MM 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 — BIOMET MICROFIXATION, INC
- 1.5MM SYSTEM — BIOMET MICROFIXATION, INC
- RAPIDFIRE® SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC — BIOMET MICROFIXATION, INC
- STERILE TRAC — BIOMET MICROFIXATION, INC
- STERILE TRAC — BIOMET MICROFIXATION, INC
- STERILE TRAC — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI 1c702e39-296b-42f1-be15-e6d167a45c9c 35 fields · synced Jul 17, 2026