Identity
- Trade Name
- restor3d Osteotomy Wedge FDA UDI
- Generic Name
- Metallic osteotomy fusion cage, non-customized FDA UDI
- Device Name
- Titanium (Ti-6AI-4V) Wedge, Evans, Small Footprint, 12mm Thickness FDA UDI
- Model / Reference
- 1101-18161218 FDA UDI
- Description
- Titanium (Ti-6AI-4V) Wedge, Evans, Small Footprint, 12mm Thickness FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097500119 FDA UDI
- 510(k) Number
- K191047 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Metallic osteotomy fusion cage, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
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: Metallic osteotomy fusion cage, non-customized
restor3d Osteotomy Wedge by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic osteotomy fusion cage, non-customized.
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- Paragon 28 Bone Wedge System — Paragon 28 · Class II
- 4WEB Medical — 4Web Medical, Inc. · Class II
- BIOFOAM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Foot Osteotomy Wedge System — Tyber Medical · Class II
- 4WEB Medical — 4Web Medical, Inc. · Class II
Cleared under the same submission
K191047 also covers:
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — Restor3D
- restor3d Osteotomy Wedge — 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 21293481-c395-4f38-86a4-cd56ce7d31ec 34 fields · synced May 31, 2026