Plateau Spacer System 113-564

GUDID 00190837045401

Barrel Shaver, 8mm

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837045401
NIH Device Record Keyb93355cf-43cb-496c-8897-3d7c6b397bc3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau Spacer System
Version Model Number113-564
Catalog Number113-564
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
GS100190837045401 [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

[00190837045401]

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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