Identity
- Trade Name
- TranS1 FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 12, 60 mm Fixation Rod FDA UDI
- Model / Reference
- TR1-2365 FDA UDI
- Description
- AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 12, 60 mm Fixation Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815361020433 FDA UDI
- 510(k) Number
- K102334 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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: Vertebral body prosthesis
TranS1 by Quandary Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102334 also covers:
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
- TranS1 — QUANDARY MEDICAL LLC
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
- Quandary Medical Llc
Sources (1)
- FDA UDI f808d33f-a83a-4651-b488-170b50987c47 34 fields · synced May 30, 2026