Plateau-A Anterior Lumbar Spacer System

GUDID 00190837011093

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837011093
NIH Device Record Key2720e6b5-0162-4d1f-90bf-441d225156b7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-A Anterior Lumbar Spacer System
Version Model Number64-3024-617
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
GS100190837011093 [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

[00190837011093]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-06-20

On-Brand Devices [Plateau-A Anterior Lumbar Spacer System]

0019083701122264-3428-619
0019083701121564-3428-617
0019083701120864-3428-615
0019083701119264-3428-613
0019083701118564-3428-611
0019083701117864-3428-609
0019083701116164-3428-1219
0019083701115464-3428-1217
0019083701114764-3428-1215
0019083701113064-3428-1213
0019083701112364-3428-1211
0019083701111664-3428-1209
0019083701110964-3024-619
0019083701109364-3024-617
0019083701108664-3024-615
0019083701107964-3024-613
0019083701106264-3024-611
0019083701105564-3024-609
0019083701104864-3024-1219
0019083701103164-3024-1217
0019083701102464-3024-1215
0019083701101764-3024-1213
0019083701100064-3024-1211
0019083701099764-3024-1209

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.