Plateau-X Spacer System

GUDID 00190837016340

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837016340
NIH Device Record Key2264c6dd-b179-48b9-b237-809d3af52a83
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-X Spacer System
Version Model Number89-2250-712
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837016340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837016340]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-12-20

Devices Manufactured by Life Spine, Inc.

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00190837175382 - ARx SAI2024-12-12
00190837153410 - TruLift Lateral2024-10-25
00190837142209 - ProLift2024-10-18
00190837142278 - ProLift2024-10-18

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