Identity
- Trade Name
- restor3d Lumbar Instrumentation FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- ALIF Disc Prep - Level 3 FDA UDI
- Model / Reference
- 5113-B0013 FDA UDI
- Description
- ALIF Disc Prep - Level 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097509990 FDA UDI
- 510(k) Number
- K234087 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Instrument tray, reusable 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
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
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
Category: Instrument tray, reusable
restor3d Lumbar Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K234087 also covers:
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
- restor3d Lumbar Instrumentation — Restor3D
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
- Restor3D
Sources (1)
- FDA UDI 23430ae6-a24a-4591-8c92-5cf28729f0a2 34 fields · synced Jun 6, 2026