CoLink Mfx C02 N0061

GUDID 00810021866482

LISFRANC TARGETING GUIDE, GUIDE CLAMP, SUB-ASSEMBLY

IN2BONES USA, LLC

Surgical drill guide, reusable
Primary Device ID00810021866482
NIH Device Record Key3b79dea6-9526-42d0-9bea-e089e9927e75
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoLink Mfx
Version Model NumberC02 N0061
Catalog NumberC02 N0061
Company DUNS079700711
Company NameIN2BONES USA, LLC
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 Usefalse
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

Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021866482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


[00810021866482]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-12-31
Device Publish Date2024-12-10

On-Brand Devices [CoLink Mfx]

00810021866512LISFRANC TARGETING GUIDE, ASSEMBLY
00810021866499LISFRANC TARGETING GUIDE, RATCHET TUBE, SUB-ASSEMBLY
00810021866482LISFRANC TARGETING GUIDE, GUIDE CLAMP, SUB-ASSEMBLY
00810021866475LISFRANC SCREW DEPTH GAUGE
00810021866468LISFRANC K-WIRE GUIDE, Ø1.6 MM
00810021866451LISFRANC TARGETING GUIDE, ROD
00810021866444LISFRANC DRIVER, T15, CANNULATED, NON-STERILE
00810021866437LISFRANC DRILL, Ø2.7 MM, CANNULATED, NON-STERILE
00810021866420LisFranc Driver, T15, Cannulated, Sterile, Single-Use
00810021866413Lisfranc Drill, Ø2.7 mm, Cannulated, Sterile, Single-Use
00810021864815MEDIAL COLUMN NCM PLATE TRIAL, STANDARD
00810021864808MEDIAL COLUMN TNC PLATE TRIAL, STANDARD
00810021864792MEDIAL COLUMN BRIDGE PLATE TRIAL, STANDARD
00810021864785TN PLATE TRIAL, STANDARD
00810021864778NC PLATE TRIAL, STANDARD
008100218647612ND/3RD LISFRANC PLATE TRIAL, LARGE
008100218647542ND/3RD LISFRANC PLATE TRIAL, SMALL
008100218647471ST/2ND LISFRANC PLATE TRIAL, SMALL, RIGHT
008100218647301ST/2ND LISFRANC PLATE TRIAL, SMALL, LEFT
008100218647231ST/2ND LISFRANC PLATE TRIAL, LARGE, RIGHT
008100218647091ST TMT LISFRANC PLATE TRIAL
00810021864693CoLink Mfx, TRANSVERSE WIRE GUIDE, Ø4.0 CoLag SCREW

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