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FDA 510(k)

CoLink™ Afx Plating System

K-Number: K181113 · 2018-06-15

ApplicantIn2bones USA, LLC
Decision Date2018-06-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink™ Afx Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K181113. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLink™ Afx Plating System?

CoLink™ Afx Plating System is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is In2bones USA, LLC. The 510(k) number is K181113.

When did CoLink™ Afx Plating System receive FDA 510(k) clearance?

CoLink™ Afx Plating System received FDA 510(k) clearance on 2018-06-15, under 510(k) number K181113.

Who is the listed applicant for CoLink™ Afx Plating System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink™ Afx Plating System?

The FDA product code for CoLink™ Afx Plating System is HRS.

Other records listing In2bones USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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