Peridot Intervertebral body fusion system

FDA UDI

Class II (US FDA UDI)

by GBS Commonwealth Co., Ltd.

Identity

Trade Name: Peridot Intervertebral body fusion system FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Model / Reference: L362-D2A2 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800056262580 FDA UDI
510(k) Number: K192026 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Polymeric spinal interbody fusion cage

The Peridot Intervertebral body fusion system is a medical device designed to treat degenerative disc disease (DDD) by providing mechanical stability and facilitating bone fusion between two contiguous vertebral bodies. Made of non-bioabsorbable synthetic polymer, the device features a hollow, porous design with threaded and/or fenestrated geometry.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
CEZANNE — CTL Medical Corporation · Class II

Cleared under the same submission

K192026 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 57d0c6a9-96fd-4066-974d-76d06bb7403c 33 fields · synced Jul 30, 2026