Plateau Spacer System 129-1157

GUDID 00190837048259

Plateau-LO 10mm x 42mm x 12mm, 12 degree Modified Hudson Tri

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837048259
NIH Device Record Keyb2852551-9240-439d-9cc7-0635a7c39c9a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau Spacer System
Version Model Number129-1157
Catalog Number129-1157
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
GS100190837048259 [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

[00190837048259]

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 Spacer System]

0019083701098051-1028-14
0019083701097351-1028-13
0019083701096651-1024-14
0019083701095951-1024-13
0019083701094251-1024-12
0019083701093551-1024-11
0019083701092851-1024-10
0019083701091151-1024-09
0019083701090451-1024-08
0019083701089851-1028-12
0019083701088151-1028-11
0019083701087451-1028-10
0019083701086751-1028-09
0019083701085051-1028-08
0019083701084355-1032-14
0019083701083655-1032-13
0019083701082955-1032-12
0019083701081255-1032-11
0019083701080555-1032-10
0019083701079955-1032-09
0019083701078255-1032-08
0019083701077555-1027-14
0019083701076855-1027-13
0019083701075155-1027-07
0019083701074455-1027-06
0019083701073755-1027-12
0019083701072055-1027-11
0019083701071355-1027-10
0019083701070655-1027-09
0019083701069055-1027-08
0019083701068335-1027-14
0019083701067635-1027-13
0019083701066935-1027-07
0019083701065235-1027-06
0019083701064535-1027-12
0019083701063835-1027-11
0019083701062135-1027-10
0019083701061435-1027-09
0019083701060735-1027-08
0019083701059152-1032-14
0019083701058452-1032-13
0019083701057752-1032-07
0019083701056052-1032-06
0019083701055352-1032-12
0019083701054652-1032-11
0019083701053952-1032-10
0019083701052252-1032-09
0019083701051552-1032-08
0019083701050852-1030-14
0019083701049252-1030-13

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