Pro-Link Stand-Alone Cervical Spacer System 129-466

GUDID 00190837060299

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837060299
NIH Device Record Key3a8d49df-24e7-4853-8fe0-032058a5688a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Link Stand-Alone Cervical Spacer System
Version Model Number129-466
Catalog Number129-466
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
GS100190837060299 [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

[00190837060299]

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 Stand-Alone Cervical Spacer System]

0019083701377624-1613-12
0019083701376924-1613-11
0019083701375224-1613-10
0019083701374524-1613-09
0019083701373821-1613-08
0019083701372121-1613-07
0019083701371421-1613-06
0019083701370721-1613-05
0019083701369123-1613-712
0019083701368423-1613-711
0019083701367723-1613-710
0019083701366023-1613-709
0019083701365320-1613-708
0019083701364620-1613-707
0019083701363920-1613-706
0019083701362220-1613-705
00190837013615129-314
00190837013608129-312
00190837013592129-310
00190837013585129-214
00190837013578129-212
00190837013561129-210
00190837013554129-114
00190837013547129-112
00190837013530129-110
00190837013523129-014
00190837013516129-012
00190837013509129-010
00190837013493129-002
001908370606952018-0058
001908370606882018-0057
001908370606712018-0042
001908370606642018-0004
001908370606572018-0003
001908370606402017-0137
001908370606332017-0136
001908370606262017-0135
001908370606192017-0055
0019083706060220-1613-709T
001908370605962016-0244
001908370605892016-0243
001908370605722016-0242
001908370605652015-0126
001908370605582015-0125
001908370605412015-0114-1
001908370605342015-0113
001908370605272015-0062
001908370605102015-0061-3
001908370605032015-0061
001908370604972015-0005

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