Kinex

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: KINEX FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: KINEX Bioactive Gel, 2cc FDA UDI
Model / Reference: 8115.0202S FDA UDI
Description: KINEX Bioactive Gel, 2cc FDA UDI

Identifiers

Primary DI / UDI-DI: 00889095206159 FDA UDI
510(k) Number: K130392 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 2 Milliliter FDA UDI

Category: Synthetic bone graft

Kinex by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic bone graft.

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OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K130392 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 14aaba94-9958-4e12-8fff-0a641da8fbdb 36 fields · synced May 30, 2026