Colink Plating System
K-Number: K163293 · 2017-05-05
ApplicantIn2bones USA, LLC
Decision Date2017-05-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Colink Plating System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2017-05-05 under approval number K163293. 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 Plating System?
Colink Plating System is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by In2bones USA, LLC. The 510(k) number is K163293.
When was Colink Plating System approved by the FDA?
Colink Plating System received FDA 510(k) clearance on 2017-05-05, under approval number K163293.
What company makes Colink Plating System?
Colink Plating System is manufactured by In2bones USA, LLC.
What is the FDA product code for Colink Plating System?
The FDA product code for Colink Plating System is HRS.
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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.