Fortify

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: FORTIFY FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: FORTIFY 20mm Upper Endplate, 21x23mm Footprint, 4deg FDA UDI
Model / Reference: 151.413 FDA UDI
Description: FORTIFY 20mm Upper Endplate, 21x23mm Footprint, 4deg FDA UDI

Identifiers

Primary DI / UDI-DI: 00889095043778 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Depth — 21 Millimeter FDA UDI
Width — 23 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.

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Novel — ALPHATEC SPINE, INC. · Class II

Cleared under the same submission

K112756 also covers:

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 fe04c82d-cde6-442d-aa45-609b57970117 36 fields · synced Jun 1, 2026