Plateau C 113-1436

GUDID 00190837093662

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837093662
NIH Device Record Keyfbf0e892-0e0d-45f7-8ae4-8d6c2d8ee592
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau C
Version Model Number113-1436
Catalog Number113-1436
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
GS100190837093662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837093662]

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 C]

00190837094607113-726
00190837094591113-547
00190837094034113-1444
00190837093846113-1744
00190837093839113-1743
00190837093822113-1742
00190837093815113-1741
00190837093808113-1740
00190837093792113-1739
00190837093785113-1738
00190837093778113-1737
00190837093761113-1736
00190837093754113-1735
00190837093747114-1444
00190837093730113-1443
00190837093723113-1442
00190837093716113-1441
00190837093709113-1440
00190837093693113-1439
00190837093686113-1438
00190837093679113-1437
00190837093662113-1436
00190837093655113-1435
00190837093648113-1044
00190837093631113-1043
00190837093624113-1042
00190837093617113-1038
00190837093600113-1036
00190837093594113-1344
00190837093587113-1343
00190837093570113-1342
00190837093563113-1338
00190837093556113-1337
00190837093549113-1335
00190837093532113-1714
00190837093525113-1713
00190837093518113-889
00190837093501113-888
00190837093495113-757
00190837093488113-987
00190837093471113-986
00190837093464113-545
00190837093457113-544
00190837093440113-543
00190837093433113-542
00190837093426113-541
00190837093419113-540
00190837093402113-539
00190837093396113-538
00190837093389113-1014

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