FDA.reportPublic FDA data

CoLink Cfx

Primary DI
00810021862064
Brand
CoLink Cfx
Company
In2Bones USA, LLC
Model
P80 ST131
Catalog number
P80 ST131
Device description
CoLink CFX Perimeter Plate, Small, Right
Published
2020-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200762000CoLink Cfx Plating SystemIn2bones USA, LLC2020-04-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021862064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021862064008100218620648100218620640810021862064

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
079700711
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38101755018838IBS-BG01 N0251G01 N02512026-09-21
38101755018845IBS-BG01 N0252G01 N02522026-09-21
008100218611735MSP06 N0241P06 N02412019-06-14
008179060297345MSP06 N0261P06 N02612019-06-14
008179060297415MSP06 N0271P06 N02712019-06-14
008179060297585MSP06 N0281P06 N02812019-06-14
008179060297655MSP06 N0291P06 N02912019-06-14
00817906027921CoLinkP04 N0012P04 N00122018-10-22
00817906027945CoLinkP04 N0101P04 N01012018-10-22
00817906027952CoLinkP04 N0102P04 N01022018-10-22
00817906027969CoLinkP04 N0103P04 N01032018-10-22
00817906027976CoLinkP04 N0104P04 N01042018-10-22
00817906027983CoLinkP04 N0105P04 N01052018-10-22
00817906027990CoLinkP04 N0131P04 N01312018-10-22
00817906028003CoLinkP04 N0132P04 N01322018-10-22
00817906028010CoLinkP04 N0141P04 N01412018-10-22
00817906028027CoLinkP04 N0142P04 N01422018-10-22
00817906028034CoLinkP04 N0151P04 N01512018-10-22
00817906028041CoLinkP04 N0152P04 N01522018-10-22
00817906028058CoLinkP04 N0161P04 N01612018-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024346DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06
00842188115424Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188115431Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188116636Locking PlatesTrimed, INC.HRS2017-05-19
00842188116643Locking PlatesTrimed, INC.HRS2017-05-19
00842188116650Locking PlatesTrimed, INC.HRS2017-05-19
00815432023592DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023608DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023615DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023622DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023639DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023646DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023653DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023660DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023677DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10