Identity
- Trade Name
- STERILE TRAC SYSTEM 12 PACK FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- SP-ST-7308-12 FDA UDI
Identifiers
- Catalog Number
- SP-ST-7308-12 FDA UDI
- Primary DI / UDI-DI
- 00888233020039 FDA UDI
- 510(k) Number
- K972322 FDA UDI
- FDA Product Code
- HRS FDA UDIJEY FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable 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 bone screw, non-bioabsorbableCranial bur hole cover
Sterile Trac System 12 Pack by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur hole cover.
- Cranial COVER “14 mm / 13 mm” — NEOS SURGERY SL · Class II
- Cranial LOOP XL — NEOS SURGERY SL · Class II
- Cranial COVER “10-12 mm” — NEOS SURGERY SL · Class II
- Speedy Flap — Jeil Medical Corporation · Class II
- Burr Hole Cover — Neuropace, Inc. · Class II
- Cranial LOOP L — NEOS SURGERY SL · Class II
- Speedy Flap — Jeil Medical Corporation · Class II
- Cranial LOOP — NEOS SURGERY SL · Class II
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 236f7544-2c35-4859-96d2-9ab79bba5bd6 35 fields · synced Jun 6, 2026