Signature

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: SIGNATURE FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: SIGNATURE TLIF TPS Spacer, MIS, Large, 11mm FDA UDI
Model / Reference: 368.331CS FDA UDI
Description: SIGNATURE TLIF TPS Spacer, MIS, Large, 11mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00889095239058 FDA UDI
510(k) Number: K143578 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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: Width — 11 Millimeter FDA UDI
Height — 11 Millimeter FDA UDI
Length — 33 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

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

Similar devices

Also classified as Metallic spinal interbody fusion cage.

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CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

K143578 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 35fae875-849a-4f3e-9f95-081c7fd0608a 35 fields · synced May 30, 2026