Identity
- Trade Name
- TALON FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- 90mm Flex 5.5mm Pre-Bent Rod FDA UDI
- Model / Reference
- T80090-C FDA UDI
- Description
- 90mm Flex 5.5mm Pre-Bent Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840916110925 FDA UDI
- FDA Product Code
- MNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Talon by Spinal Elements, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spinal Elements, Inc.
Sources (1)
- FDA UDI 14b286ef-6fe7-4b82-9634-1a613dff31e7 34 fields · synced Jun 6, 2026