Tarsa Link Bunion 154-001

GUDID 00190837066383

Tarsa-Link Bunion Lock Plate

Life Spine, Inc.

Polymeric osteotomy fusion cage

• Primary Device ID: 00190837066383
• NIH Device Record Key: a5fac2c5-8f9b-49b8-be59-77358f1713ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tarsa Link Bunion
• Version Model Number: 154-001
• Catalog Number: 154-001
• 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: true
• 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	00190837066383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161037

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

Moist Heat or Steam Sterilization

[00190837066383]

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 Bunion]

• 00190837066505: C-Shaped 8mm Trial
• 00190837066499: C-Shaped 6mm & 7mm Trial
• 00190837066482: C-Shaped 4mm & 5mm Trial
• 00190837066475: Tarsa-Link Bunion Installer
• 00190837066468: Bunion Spreader
• 00190837066451: Implant Installer, Bunion
• 00190837066444: Tarsa-Link Bunion Wedge Screw Caddy
• 00190837066437: 18mm x 9mm, Tarsa-Link C-Shaped Wedge Implant Caddy
• 00190837066420: Straight Drill, 2.3mm
• 00190837066413: 2.0mm, Hex Straight Screwdriver
• 00190837066406: 20mm Drill
• 00190837066390: Adjustable Drill Guide
• 00190837066383: Tarsa-Link Bunion Lock Plate
• 00190837066376: Tarsa-Link C-Shaped Wedge System Tray, Base
• 00190837066369: Tarsa-Link C-Shaped Wedge System Tray, Insert
• 00190837066352: Tarsa-Link C-Shaped Wedge System Tray, Lid
• 00190837066345: 114-220
• 00190837022693: 18mm x 9mm x 8mm, Tarsa-Link C-Shaped Wedge, Midline
• 00190837022686: 18mm x 9mm x 7mm, Tarsa-Link C-Shaped Wedge, Midline
• 00190837022679: 18mm x 9mm x 6mm, Tarsa-Link C-Shaped Wedge, Midline
• 00190837022662: 18mm x 9mm x 5mm, Tarsa-Link C-Shaped Wedge, Midline
• 00190837022655: 18mm x 9mm x 4mm, Tarsa-Link C-Shaped Wedge, Midline
• 00190837022648: Variable Angle Screw, 2.7mm x 20mm
• 00190837022631: Variable Angle Screw, 2.7mm x 18mm
• 00190837022624: Variable Angle Screw, 2.7mm x 16mm
• 00190837022617: Variable Angle Screw, 2.7mm x 14mm
• 00190837022600: Variable Angle Screw, 2.7mm x 12mm
• 00190837022594: Variable Angle Screw, 2.7mm x 10mm
• 00190837022587: Variable Angle Screw, 2.7mm x 8mm
• 00190837022570: Variable Angle Screw, 2.3mm x 20mm
• 00190837022563: Variable Angle Screw, 2.3mm x 18mm
• 00190837022556: Variable Angle Screw, 2.3mm x 16mm
• 00190837022549: Variable Angle Screw, 2.3mm x 14mm
• 00190837022532: Variable Angle Screw, 2.3mm x 12mm
• 00190837022525: Variable Angle Screw, 2.3mm x 10mm
• 00190837022518: Variable Angle Screw, 2.3mm x 8mm