Tarsa-Link Wedge Fixation System 2016-0026

GUDID 00190837063771

Tarsa-Link Dual Barrel Guide/Inserter, Size 5-8

Life Spine, Inc.

Polymeric osteotomy fusion cage

• Primary Device ID: 00190837063771
• NIH Device Record Key: 186434da-b40b-4aa2-b391-bce50e971057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tarsa-Link Wedge Fixation System
• Version Model Number: 2016-0026
• Catalog Number: 2016-0026
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837063771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150368

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

[00190837063771]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

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

• 00190837015565: 27-2219-712
• 00190837015558: 27-2219-711
• 00190837015541: 27-2219-710
• 00190837015534: 27-2219-709
• 00190837015527: 27-1613-712
• 00190837015510: 27-1613-711
• 00190837015503: 27-1613-710
• 00190837015497: 27-1613-709
• 00190837015480: 26-2219-708
• 00190837015473: 26-2219-707
• 00190837015466: 26-2219-706
• 00190837015459: 26-2219-705
• 00190837015442: 26-1613-708
• 00190837015435: 26-1613-707
• 00190837015428: 26-1613-706
• 00190837015411: 26-1613-705
• 00190837015404: 154-2-020
• 00190837015398: 154-2-018
• 00190837015381: 154-2-016
• 00190837015374: 154-2-014
• 00190837015367: 154-2-012
• 00190837015350: 154-2-010
• 00190837015343: 154-1-020
• 00190837015336: 154-1-018
• 00190837015329: 154-1-016
• 00190837015312: 154-1-014
• 00190837015305: 154-1-012
• 00190837015299: 154-1-010
• 00190837063788: Tarsa-Link Dual Barrel Guide/Inserter, Size 9-12
• 00190837063771: Tarsa-Link Dual Barrel Guide/Inserter, Size 5-8
• 00190837063764: 22mm x 19mm x 11mm/12mm Trial
• 00190837063757: 22mm x 19mm x 9mm/10mm Trial
• 00190837063740: 22mm x 19mm x 7mm/8mm Trial
• 00190837063733: 22mm x 19mm x 5mm/6mm Trial
• 00190837063726: 16mm x 13mm x 11mm/12mm Trial
• 00190837063719: 16mm x 13mm x 9mm/10mm Trial
• 00190837063702: 16mm x 13mm x 7mm/8mm Trial
• 00190837063696: 16mm x 13mm x 5mm/6mm Trial
• 00190837063689: Tarsa-Link Installer 16mm x 13mm
• 00190837063672: Tarsa-Link Installer 22mm x 19mm
• 00190837063665: Tarsa-Link 16x13 Installer
• 00190837063658: Tarsa-Link 22x19 Installer
• 00190837063641: Tarsa-Link Fixation Pin
• 00190837063634: Tarsa-Link 20mm Drill
• 00190837063627: Tarsa-Link Adjustable Drill Guide
• 00190837063610: Tarsa-Link Bunion Fixation Pin
• 00190837063603: Guide Pin Spreader
• 00190837063597: Bone Spreader, Smooth
• 00190837063580: Tarsa-Link Ti Stand-Alone Wedge Fixation System
• 00190837063573: Tarsa-Link Sterilization Tray Bottom