Identity
- Trade Name
- FORTIFY FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- FORTIFY 12mm Lower Endplate, 14mm Footprint, 3.5deg, No Spikes FDA UDI
- Model / Reference
- 151.362 FDA UDI
- Description
- FORTIFY 12mm Lower Endplate, 14mm Footprint, 3.5deg, No Spikes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889095043464 FDA UDI
- 510(k) Number
- K112756 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Depth — 14 Millimeter FDA UDIWidth — 14 Millimeter FDA UDI
Category: Vertebral body prosthesis
Fortify by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
- CASCADIA™ Interbody System — K2M, INC. · Class II
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- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
- Novel — ALPHATEC SPINE, INC. · Class II
Cleared under the same submission
K112756 also covers:
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
- FORTIFY — GLOBUS MEDICAL, INC.
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
- Globus Medical, Inc.
Sources (1)
- FDA UDI 1b117550-ee30-4d6f-ae8a-dd65f7cc8351 36 fields · synced May 30, 2026