Identity
- Trade Name
- restor3d Lumbar Implant FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 18° FDA UDI
- Model / Reference
- 1113-L1018 FDA UDI
- Description
- Lumbar ALIF Implant, Large Footprint, 30x38, 10 mm Height, 18° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097508269 FDA UDI
- 510(k) Number
- K220523 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Interspinous spinal fixation implant 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
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: Interspinous spinal fixation implant
restor3d Lumbar Implant by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interspinous spinal fixation implant.
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
Cleared under the same submission
K220523 also covers:
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — Restor3D
- restor3d Lumbar Implant — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Restor3D
Sources (1)
- FDA UDI 7ed7aa05-a302-4853-84ae-f12a49bdfaa1 34 fields · synced May 31, 2026