Ti Pro-Link Stand-Alone Cervical System 129-396

GUDID 00190837066338

Pro-Link 14 x 11 Implant Caddy

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837066338
NIH Device Record Key21e913dd-06d6-424b-a3b8-21ecb20471eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi Pro-Link Stand-Alone Cervical System
Version Model Number129-396
Catalog Number129-396
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
GS100190837066338 [Primary]

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837066338]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-06

On-Brand Devices [Ti Pro-Link Stand-Alone Cervical System]

0019083701772924-1613-12T
0019083701771224-1613-11T
0019083701770524-1613-10T
0019083701769924-1613-09T
0019083701768221-1613-08T
0019083701767521-1613-07T
0019083701766821-1613-06T
0019083701765121-1613-05T
0019083701764423-1613-712T
0019083701763723-1613-711T
0019083701762023-1613-710T
0019083701761323-1613-709T
0019083701760620-1613-708T
0019083701759020-1613-707T
0019083701758320-1613-706T
0019083701757620-1613-705T
00190837066338Pro-Link 14 x 11 Implant Caddy
00190837066321Pro-Link Screw Driver, Fixed Angle
00190837066314Pro-Link Tap 3.0mm, Fixed Angle
00190837066307Pro-Link Drill 3.0mm, Fixed Angle

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