Plateau Spacer System

FDA UDI

Class II (US FDA UDI)

by Life Spine, Inc.

Identity

Trade Name: Plateau Spacer System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: PLATEAU Interbody, Curved, Bulleted, 11mm 28mm x 8mm, 0° FDA UDI
Model / Reference: 55-1028-08 FDA UDI
Description: PLATEAU Interbody, Curved, Bulleted, 11mm 28mm x 8mm, 0° FDA UDI

Identifiers

Catalog Number: 55-1028-08 FDA UDI
Primary DI / UDI-DI: 00190837026745 FDA UDI
510(k) Number: K111569 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

Yes

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Polymeric spinal interbody fusion cage

The Plateau Spacer System is a non-surgical intervertebral fusion device designed to treat degenerative disc disease (DDD) by providing mechanical stability and sufficient space for therapeutic spinal bone fusion. Made of polymeric synthetic polymer, the device offers optimal fixation with included fixation screws and devices.

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
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · 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

Cleared under the same submission

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: Life Spine, Inc.

Sources (1)

FDA UDI 45410494-867e-478b-ba2f-d811a9383af9 35 fields · synced Jul 31, 2026