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: L363-B571 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800056280805 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 innovative medical device designed to treat degenerative disc disease (DDD) by providing mechanical stability and sufficient space for therapeutic spinal bone fusion. Featuring a non-bioabsorbable synthetic polymer construction, this interbody fusion cage offers excellent biocompatibility and durability, making it an ideal solution for patients requiring intervertebral body fusion.

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 34af4e24-75c1-4e2f-a80b-a2d9bcc4d762 33 fields · synced Jul 30, 2026