Pro-Link Ti 129-458

GUDID 00190837080839

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837080839
NIH Device Record Keyebe3d7d4-b5a5-4fe2-9e3a-85bb6d70f358
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Link Ti
Version Model Number129-458
Catalog Number129-458
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
GS100190837080839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837080839]

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 [Pro-Link Ti]

00190837081195129-468
00190837081188129-445
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00190837081164113-886
00190837081157113-885
00190837081140113-884
00190837081133113-883
00190837081126113-882
00190837081119113-881
00190837081102113-880
00190837081096113-1722
00190837081089113-1721
00190837081072113-1720
00190837081065113-1719
00190837081058113-1718
00190837081041113-1717
00190837081034113-1716
00190837081027113-1715
00190837081010113-1022
00190837081003113-1021
00190837080990113-1020
00190837080983113-1019
00190837080976113-1018
00190837080969113-1017
00190837080952113-1016
00190837080945113-1015
00190837080938113-1012
00190837080921113-1011
00190837080914113-1010
00190837080907113-1009
00190837080891113-1008
00190837080884113-1007
00190837080877113-1006
00190837080860113-1005
00190837080853129-471
00190837080846129-460
00190837080839129-458
00190837080822129-451
00190837080815129-393
00190837080808129-390
00190837080792129-379
00190837080785129-377
00190837080778129-362
00190837080761129-361
00190837080754129-360
00190837080747129-351
00190837080730113-741
00190837080723113-1712
00190837080716113-1711
00190837080709113-1710

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