Peridot-PT Intervertebral body fusion system

FDA UDI

Class II (US FDA UDI)

by GBS Commonwealth Co., Ltd.

Identity

Trade Name: Peridot-PT Intervertebral body fusion system FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Model / Reference: L656-8250S FDA UDI

Identifiers

Primary DI / UDI-DI: 08809987226203 FDA UDI
510(k) Number: K233839 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

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Manufacturing Date

Yes

FDA UDI

Category: Metallic spinal interbody fusion cage

Our Peridot-PT Intervertebral body fusion system is a cutting-edge medical device designed to provide stable and secure bone fusion between two contiguous vertebral bodies. The device features a hollow, porous, threaded, and/or fenestrated cylindrical or disc-shaped design made of titanium, allowing for optimal osseointegration and mechanical stability.

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
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
ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II
Matrixx System — NEXXT SPINE LLC · Class II

Cleared under the same submission

K233839 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: GBS Commonwealth Co., Ltd.

Sources (1)

FDA UDI 7ea0295b-3888-47b8-afb9-541a92cf2c0e 33 fields · synced Jul 30, 2026