Plateau-V Spacer System

GUDID 00190837011802

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837011802
NIH Device Record Key65ecb6b2-f636-41af-af02-d4efb982a81e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-V Spacer System
Version Model Number61-1228-714
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
GS100190837011802 [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

[00190837011802]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-06-09

On-Brand Devices [Plateau-V Spacer System]

0019083701185761-1224-715
0019083701184061-1224-714
0019083701183361-1224-713
0019083701182661-1224-712
0019083701181961-1228-715
0019083701180261-1228-714
0019083701179661-1228-713
0019083701178961-1228-712
00190837029203PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 18mm, 7°
00190837029197PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 17mm, 7°
00190837029180PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 16mm, 7°
00190837029173PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 15mm, 7°
00190837029166PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 14mm, 7°
00190837029159PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 13mm, 7°
00190837029142PLATEAU-V Interbody, Straight, Bulleted, 12mm x 32mm x 12mm, 7°
00190837029135PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 18mm, 7°
00190837029128PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 17mm, 7°
00190837029111PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 16mm, 7°
00190837029104PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 15mm, 7°
00190837029098PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 14mm, 7°
00190837029081PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 13mm, 7°
00190837029074PLATEAU-V Interbody, Straight, Bulleted, 12mm x 30mm x 12mm, 7°
00190837029067PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 18mm, 7°
00190837029050PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 17mm, 7°
00190837029043PLATEAU-V Interbody, Straight, Bulleted, 12mm x 28mm x 16mm, 7°
00190837029036PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 18mm, 7°
00190837029029PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 17mm, 7°
00190837029012PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 16mm, 7°
00190837029005PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 15mm, 7°
00190837028992PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 14mm, 7°
00190837028985PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 13mm, 7°
00190837028978PLATEAU-V Interbody, Straight, Bulleted, 12mm x 26mm x 12mm, 7°
00190837028961PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 18mm, 7°
00190837028954PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 17mm, 7°
00190837028947PLATEAU-V Interbody, Straight, Bulleted, 12mm x 24mm x 16mm, 7°
00190837028930PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 18mm, 7°
00190837028923PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 17mm, 7°
00190837028916PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 16mm, 7°
00190837028909PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 15mm, 7°
00190837028893PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 14mm, 7°
00190837028886PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 13mm, 7°
00190837028879PLATEAU-V Interbody, Straight, Bulleted, 12mm x 22mm x 12mm, 7°

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