Identity
- Trade Name
- Medtronic Reusable Instruments FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- TRIAL X0524005 5MM POSTED DETACHABLE FDA UDI
- Model / Reference
- X0524005 FDA UDI
- Description
- TRIAL X0524005 5MM POSTED DETACHABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000954062 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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
Category: Spinal implant trial
Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal implant trial.
- Novel — ALPHATEC SPINE, INC. · Class II
- Scarlet AL-T Instruments — Spineart · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- MLX — Nuvasive, Inc. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- ROI-A — Ldr Spine USA · Class II
- IdentiTi — ALPHATEC SPINE, INC. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI e3603db7-d983-44ba-bf29-91b63dd5f89b 34 fields · synced May 30, 2026