FDA.reportPublic FDA data

CoLink

Primary DI
00817906028065
Brand
CoLink
Company
In2Bones USA, LLC
Model
P04 N0171
Catalog number
P04 N0171
Device description
H-Plate Plate Trial, SM
Published
2018-10-22
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
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163293000Colink™ Plating SystemIn2bones USA, LLC2017-05-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817906028065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817906028065008179060280658179060280650817906028065

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
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
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550252BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
08057717550276BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
B650SCS370450StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370500StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
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B650SCS370600StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370650StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830950StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX831000StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31