CorticaLINK MI 80-4974

GUDID 00817329025108

CL MI Implant Tray 1

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00817329025108
• NIH Device Record Key: 2d80ecca-e5c0-426c-9e3f-7ab0ce93d99c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorticaLINK MI
• Version Model Number: 80-4974
• Catalog Number: 80-4974
• Company DUNS: 067584601
• Company Name: LINKSPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817329025108 [Primary]

FDA Product Code

• LRP: Tray, Surgical

Sterilization

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

[00817329025108]

Moist Heat or Steam Sterilization

[00817329025108]

Moist Heat or Steam Sterilization

[00817329025108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-07-06

On-Brand Devices [CorticaLINK MI]

• 00817329025818: CorticaLINK MI K-Wire Caddy
• 00817329025641: CorticaLINK MI Set
• 00817329025122: CL MI Guidewire Tube
• 00817329025115: CL MI Implant Tray 2
• 00817329025108: CL MI Implant Tray 1
• 00817329025092: CL MI Reduction Tray
• 00817329025085: CL MI Handles Tray
• 00817329025078: CL MI Insertion Instrument Tray
• 00817329025061: CL MI Prep Instrument Tray
• 00817329025054: Lag Screw Caddy
• 00817329025047: Added Rod Length Caddy
• 00817329025030: CLMI Tulip Wedge
• 00817329025023: CLMI Tissue Splitter, Small
• 00817329025016: Rod Length Indicator
• 00817329025009: Trocar Stylet
• 00817329024996: Stylet Handle
• 00817329024804: Set Screw Caddy
• 00817329024644: Counter Torque Reducer Insert
• 00817329023470: Reduction Assist
• 00817329023463: Reduction Cap Release
• 00817329023456: Large Reducer
• 00817329023449: Reduction Cap
• 00817329023432: Tulip Cap Release
• 00817329023425: Tulip Cap
• 00817329023418: Tab Breaker
• 00817329023401: Screw Head Adjuster
• 00817329023395: Final Tightener, C/D
• 00817329023388: Final Tightener
• 00817329023371: Compressor Distractor Handle
• 00817329023364: Compressor Distractor
• 00817329023357: Counter Torque Wrench
• 00817329023340: Counter Torque Sleeve
• 00817329023333: Offset Rod Inserter
• 00817329023326: Locking Cap Starter
• 00817329023319: Locking Cap Starter Anti-Splay
• 00817329023302: Tissue Splitter
• 00817329023296: Rod Caliper
• 00817329023289: Locking Screwdriver Inner Shaft
• 00817329023272: Locking Screwdriver
• 00817329023265: Guidewire, 500mm, Blunt
• 00817329023258: Guidewire, 500mm, Trocar
• 00817329023241: Dilator Handle
• 00817329023234: Dilator 3
• 00817329023227: Dilator 2
• 00817329023210: Dilator 1
• 00817329023180: 5.0mm Cobalt Chrome Rod: 160mm Curved
• 00817329023173: 5.0mm Cobalt Chrome Rod: 150mm Curved
• 00817329023166: 5.0mm Cobalt Chrome Rod: 140mm Curved
• 00817329023159: 5.0mm Cobalt Chrome Rod: 130mm Curved
• 00817329023142: 5.0mm Titanium Rod: 160mm Curved