Identity
- Trade Name
- Foot Osteotomy Wedge System FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- CerviFuse Lordotic Spacer, 11 x 14 x 6mm FDA UDI
- Model / Reference
- 14-0706 FDA UDI
- Description
- CerviFuse Lordotic Spacer, 11 x 14 x 6mm FDA UDI
Identifiers
- Catalog Number
- 14-0706 FDA UDI
- Primary DI / UDI-DI
- M6951407060 FDA UDI
- 510(k) Number
- K150394 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
Foot Osteotomy Wedge System by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
- Battalion Universal Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Irix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc. · Class II
- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
Cleared under the same submission
K150394 also covers:
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- ORION WEDGE — HNM TOTAL RECON LLC
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
- Foot Osteotomy Wedge System — Tyber Medical
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
- Tyber Medical
Sources (1)
- FDA UDI abb4c7c8-e4c9-4eda-b6f0-a0efd7c734f4 36 fields · synced May 30, 2026