Plateau Lo 129-1288

GUDID 00190837082796

BULLETED TLIF SIZER, 34mm x 8mm x 0°

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837082796
NIH Device Record Key4ad51bd3-00de-46fa-8292-9868471003cd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau Lo
Version Model Number129-1288
Catalog Number129-1288
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100190837082796 [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

[00190837082796]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [Plateau Lo]

00190837070373Bulleted TLIF Sizer, 14mm, 32mm Length, Modified Hudson
00190837070366Bulleted TLIF Sizer, 13mm, 32mm Length, Modified Hudson
00190837070359Bulleted TLIF Sizer, 12mm, 32mm Length, Modified Hudson
00190837070342Bulleted TLIF Sizer, 11mm, 32mm Length, Modified Hudson
00190837070335Bulleted TLIF Sizer, 10mm, 32mm Length, Modified Hudson
00190837070328Bulleted TLIF Sizer, 9mm, 32mm Length, Modified Hudson
00190837070311Bulleted TLIF Sizer, 8mm, 32mm Length, Modified Hudson
00190837070304Modified Hudson Bulleted Curved Trial, 11mm x 7mm, 0 deg
00190837070298Modified Hudson Bulleted Curved Trial, 11mm x 6mm, 0 deg
00190837070236Bulleted TLIF Sizer, 10mm, 34mm length, 12°, Modified Hudson
00190837082895BULLETED TLIF SIZER, 34mm x 16mm x 12°
00190837082888BULLETED TLIF SIZER, 34mm x 16mm x 7°
00190837082871BULLETED TLIF SIZER, 34mm x 16mm x 0°
00190837082864BULLETED TLIF SIZER, 34mm x 15mm x 0°
00190837082857BULLETED TLIF SIZER, 34mm x 14mm x 0°
00190837082840BULLETED TLIF SIZER, 34mm x 13mm x 0°
00190837082833BULLETED TLIF SIZER, 34mm x 11mm x 0°
00190837082826BULLETED TLIF SIZER, 34mm x 11mm x 0°
00190837082819BULLETED TLIF SIZER, 34mm x 10mm x 0°
00190837082802BULLETED TLIF SIZER, 34mm x 9mm x 0°
00190837082796BULLETED TLIF SIZER, 34mm x 8mm x 0°
00190837082789BULLETED TLIF SIZER, 34mm x 7mm x 0°
00190837070281Bulleted TLIF Sizer, 15mm, 34mm length, 12°, Modified Hudson
00190837070274Bulleted TLIF Sizer, 14mm, 34mm length, 12°, Modified Hudson
00190837070267Bulleted TLIF Sizer, 13mm, 34mm length, 12°, Modified Hudson
00190837070250Bulleted TLIF Sizer, 12mm, 34mm length, 12°, Modified Hudson
00190837070243Bulleted TLIF Sizer, 11mm, 34mm length, 12°, Modified Hudson
00190837070229Bulleted TLIF Sizer, 9mm, 34mm length, 12°, Modified Hudson
00190837070212Bulleted TLIF Sizer, 8mm, 34mm length, 12°, Modified Hudson
00190837070205Bulleted TLIF Sizer, 7mm, 34mm length, 12°, Modified Hudson
00190837070199Bulleted TLIF Sizer, 15mm, 34mm length, 7°, Modified Hudson
00190837070182Bulleted TLIF Sizer, 14mm, 34mm length, 7°, Modified Hudson
00190837070175Bulleted TLIF Sizer, 13mm, 34mm length, 7°, Modified Hudson
00190837070168Bulleted TLIF Sizer, 12mm, 34mm length, 7°, Modified Hudson
00190837070151Bulleted TLIF Sizer, 11mm, 34mm length, 7°, Modified Hudson
00190837070144Bulleted TLIF Sizer, 10mm, 34mm length, 7°, Modified Hudson
00190837070137Bulleted TLIF Sizer, 9mm, 34mm length, 7°, Modified Hudson D
00190837070120Bulleted TLIF Sizer, 8mm, 34mm length, 7°, Modified Hudson D
00190837070113Bulleted TLIF Sizer, 7mm, 34mm length, 7°, Modified Hudson D
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