FDA.reportPublic FDA data

CoLink Mfx

Primary DI
00810021864761
Brand
CoLink Mfx
Company
In2Bones USA, LLC
Model
C02 N1202
Catalog number
C02 N1202
Device description
2ND/3RD LISFRANC PLATE TRIAL, LARGE
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210060000CoLink Mfx Implant SystemIn2bones USA, LLC2021-03-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021864761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021864761008100218647618100218647610810021864761

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
079700711
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817906028065CoLinkP04 N0171P04 N01712018-10-22
00817906028072CoLinkP04 N0172P04 N01722018-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844758219EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758233EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758271EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
10603295552680ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555001ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555018ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555025ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555032ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555049ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555056ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555544ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12