Identity
- Trade Name
- STERILE TRAC SYSTEM FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Model / Reference
- SP-STA-1025 FDA UDI
Identifiers
- Catalog Number
- SP-STA-1025 FDA UDI
- Primary DI / UDI-DI
- 00888233020374 FDA UDI
- 510(k) Number
- K972322 FDA UDI
- FDA Product Code
- HRS FDA UDIJEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI872.4760 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 fixation plate, non-bioabsorbable, non-customized
Sterile Trac 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
K972322 also covers:
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC
- STERILE TRAC 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 4122d931-60f6-4e62-9e32-8c3c34d9ef8e 35 fields · synced May 30, 2026