Plateau Spacer System 113-583

GUDID 00190837045692

CR Block, 9.5mm

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837045692
NIH Device Record Key1e5f9fda-af7d-482c-8c4f-4947c4e3a477
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau Spacer System
Version Model Number113-583
Catalog Number113-583
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
GS100190837045692 [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

[00190837045692]

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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