Tarsa-Link Wedge Fixation System 154-298

GUDID 00190837063665

Tarsa-Link 16x13 Installer

Life Spine, Inc.

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Primary Device ID00190837063665
NIH Device Record Key21f70cb5-9442-4f0a-a5f9-6e91ec0a7140
Commercial Distribution StatusIn Commercial Distribution
Brand NameTarsa-Link Wedge Fixation System
Version Model Number154-298
Catalog Number154-298
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
GS100190837063665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


[00190837063665]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Tarsa-Link Wedge Fixation System]

0019083701556527-2219-712
0019083701555827-2219-711
0019083701554127-2219-710
0019083701553427-2219-709
0019083701552727-1613-712
0019083701551027-1613-711
0019083701550327-1613-710
0019083701549727-1613-709
0019083701548026-2219-708
0019083701547326-2219-707
0019083701546626-2219-706
0019083701545926-2219-705
0019083701544226-1613-708
0019083701543526-1613-707
0019083701542826-1613-706
0019083701541126-1613-705
00190837015404154-2-020
00190837015398154-2-018
00190837015381154-2-016
00190837015374154-2-014
00190837015367154-2-012
00190837015350154-2-010
00190837015343154-1-020
00190837015336154-1-018
00190837015329154-1-016
00190837015312154-1-014
00190837015305154-1-012
00190837015299154-1-010
00190837063788Tarsa-Link Dual Barrel Guide/Inserter, Size 9-12
00190837063771Tarsa-Link Dual Barrel Guide/Inserter, Size 5-8
0019083706376422mm x 19mm x 11mm/12mm Trial
0019083706375722mm x 19mm x 9mm/10mm Trial
0019083706374022mm x 19mm x 7mm/8mm Trial
0019083706373322mm x 19mm x 5mm/6mm Trial
0019083706372616mm x 13mm x 11mm/12mm Trial
0019083706371916mm x 13mm x 9mm/10mm Trial
0019083706370216mm x 13mm x 7mm/8mm Trial
0019083706369616mm x 13mm x 5mm/6mm Trial
00190837063689Tarsa-Link Installer 16mm x 13mm
00190837063672Tarsa-Link Installer 22mm x 19mm
00190837063665Tarsa-Link 16x13 Installer
00190837063658Tarsa-Link 22x19 Installer
00190837063641Tarsa-Link Fixation Pin
00190837063634Tarsa-Link 20mm Drill
00190837063627Tarsa-Link Adjustable Drill Guide
00190837063610Tarsa-Link Bunion Fixation Pin
00190837063603Guide Pin Spreader
00190837063597Bone Spreader, Smooth
00190837063580Tarsa-Link Ti Stand-Alone Wedge Fixation System
00190837063573Tarsa-Link Sterilization Tray Bottom

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