CorticaLINK 80-4003/025

GUDID 00817329020097

5.0mm Titanium Rod: 25mm Straight

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00817329020097
NIH Device Record Key279f507f-8e01-403c-af76-72fd81d54156
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorticaLINK
Version Model Number80-4003/025
Catalog Number80-4003/025
Company DUNS067584601
Company NameLINKSPINE, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com

Device Dimensions

Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100817329020097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817329020097]

Moist Heat or Steam Sterilization

[00817329020097]

Moist Heat or Steam Sterilization

[00817329020097]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-28
Device Publish Date2016-09-30

On-Brand Devices [CorticaLINK]

00817329025801Biased Cortical Screw: 5.0mm X 50mm
00817329025795Biased Cortical Screw: 5.0mm X 45mm
00817329025788Biased Cortical Screw: 5.0mm X 40mm
00817329025771Biased Cortical Screw: 5.0mm X 35mm
00817329025764Biased Cortical Screw: 5.0mm X 30mm
00817329025757Biased Cortical Screw: 5.0mm X 25mm
00817329025740Biased Cortical Screw: 4.5mm X 50mm
00817329025733Biased Cortical Screw: 4.5mm X 45mm
00817329025726Biased Cortical Screw: 4.5mm X 40mm
00817329025719Biased Cortical Screw: 4.5mm X 35mm
00817329025702Biased Cortical Screw: 4.5mm X 30mm
00817329025696Biased Cortical Screw: 4.5mm X 25mm
00817329025689Guide Wire Dispenser-Dark Grey
00817329025634CorticaLINK Mini Set
00817329025627CorticaLINK Full Set
00817329024989Pedicle Marker Driver
00817329024972CL Pedicle Marker
00817329024965Depth Gauge
00817329024958T20 Screwdriver
00817329024941FacetLINK Screwdriver Shaft 1of 2
00817329024934Modular Driver Shaft 1of 2
008173290247985.0mm Cortical Screw Caddy
008173290247814.5mm Cortical Screw Caddy
008173290247747.5mm Cancellous Screw Caddy
008173290247676.5mm Cancellous Screw Caddy
008173290247505.5mm Cancellous Screw Caddy
00817329024743Set Screw Caddy
00817329024736CoCr Rod Caddy
00817329024729Ti Rod Caddy
00817329024712Implant Tray #2 - Bottom
00817329024705Implant Tray #1 - Top
00817329024699Implant Insertion Instrument Tray #2 - Bottom
00817329024682Implant Insertion Instrument Tray #1 - Top
00817329024675Cortical Prep Instrument Tray - Bottom
00817329024668Cortical Prep Instrument Tray - Top
00817329024637CL Drill Guide
00817329024620Rod Gripper
00817329024613Final Tightening Shaft
00817329024446Counter Torque Wrench
00817329024439Reduction Instrument
00817329024422Outer Screw Driver Tube
00817329024415Inner Screw Driver Shaft
00817329024408Fixed 1/4 Square T-Handle
00817329024392Rod Rocker
00817329024385Head Manipulator
00817329024378Screw Height Adjuster
00817329024361Compressor
00817329024354Distractor
00817329024347Guide Wire Dispenser-Light Grey
00817329024330Lenke Pedicle Probe

Trademark Results [CorticaLINK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORTICALINK
CORTICALINK
85956589 5124583 Live/Registered
Facet-Link, Inc.
2013-06-11
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