Identity
- Trade Name
- Omnia Medical TiBrid™-SA FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- TiBrid™ SA Self Drilling Variable Tack, 6.0 x 25mm FDA UDI
- Model / Reference
- 17-1A-6025 FDA UDI
- Description
- TiBrid™ SA Self Drilling Variable Tack, 6.0 x 25mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843511128111 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Omnia Medical TiBrid™-SA by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
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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
- Omnia Medical
Sources (1)
- FDA UDI 31ac127a-b152-4aa8-8f67-cb09ec6772a5 35 fields · synced May 31, 2026