CorticaLINK 80-4017/5035

GUDID 00817329022558

Cortical Screw, Non-Cannulated: 5.0mm X 35mm

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00817329022558
• NIH Device Record Key: c107ca53-5b36-42ad-b226-ecedaf543e16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorticaLINK
• Version Model Number: 80-4017/5035
• Catalog Number: 80-4017/5035
• Company DUNS: 067584601
• Company Name: LINKSPINE, 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

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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817329022558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160722

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

[00817329022558]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-27
• Device Publish Date: 2017-05-17

On-Brand Devices [CorticaLINK]

• 00817329025801: Biased Cortical Screw: 5.0mm X 50mm
• 00817329025795: Biased Cortical Screw: 5.0mm X 45mm
• 00817329025788: Biased Cortical Screw: 5.0mm X 40mm
• 00817329025771: Biased Cortical Screw: 5.0mm X 35mm
• 00817329025764: Biased Cortical Screw: 5.0mm X 30mm
• 00817329025757: Biased Cortical Screw: 5.0mm X 25mm
• 00817329025740: Biased Cortical Screw: 4.5mm X 50mm
• 00817329025733: Biased Cortical Screw: 4.5mm X 45mm
• 00817329025726: Biased Cortical Screw: 4.5mm X 40mm
• 00817329025719: Biased Cortical Screw: 4.5mm X 35mm
• 00817329025702: Biased Cortical Screw: 4.5mm X 30mm
• 00817329025696: Biased Cortical Screw: 4.5mm X 25mm
• 00817329025689: Guide Wire Dispenser-Dark Grey
• 00817329025634: CorticaLINK Mini Set
• 00817329025627: CorticaLINK Full Set
• 00817329024989: Pedicle Marker Driver
• 00817329024972: CL Pedicle Marker
• 00817329024965: Depth Gauge
• 00817329024958: T20 Screwdriver
• 00817329024941: FacetLINK Screwdriver Shaft 1of 2
• 00817329024934: Modular Driver Shaft 1of 2
• 00817329024798: 5.0mm Cortical Screw Caddy
• 00817329024781: 4.5mm Cortical Screw Caddy
• 00817329024774: 7.5mm Cancellous Screw Caddy
• 00817329024767: 6.5mm Cancellous Screw Caddy
• 00817329024750: 5.5mm Cancellous Screw Caddy
• 00817329024743: Set Screw Caddy
• 00817329024736: CoCr Rod Caddy
• 00817329024729: Ti Rod Caddy
• 00817329024712: Implant Tray #2 - Bottom
• 00817329024705: Implant Tray #1 - Top
• 00817329024699: Implant Insertion Instrument Tray #2 - Bottom
• 00817329024682: Implant Insertion Instrument Tray #1 - Top
• 00817329024675: Cortical Prep Instrument Tray - Bottom
• 00817329024668: Cortical Prep Instrument Tray - Top
• 00817329024637: CL Drill Guide
• 00817329024620: Rod Gripper
• 00817329024613: Final Tightening Shaft
• 00817329024446: Counter Torque Wrench
• 00817329024439: Reduction Instrument
• 00817329024422: Outer Screw Driver Tube
• 00817329024415: Inner Screw Driver Shaft
• 00817329024408: Fixed 1/4 Square T-Handle
• 00817329024392: Rod Rocker
• 00817329024385: Head Manipulator
• 00817329024378: Screw Height Adjuster
• 00817329024361: Compressor
• 00817329024354: Distractor
• 00817329024347: Guide Wire Dispenser-Light Grey
• 00817329024330: Lenke Pedicle Probe