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 a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2018-06-15 under approval 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. It is manufactured by In2bones USA, LLC. The 510(k) number is K181113.
When was CoLink Afx Plating System approved by the FDA?
CoLink Afx Plating System received FDA 510(k) clearance on 2018-06-15, under approval number K181113.
What company makes CoLink Afx Plating System?
CoLink Afx Plating System is manufactured by In2bones USA, LLC.
What is the FDA product code for CoLink Afx Plating System?
The FDA product code for CoLink Afx 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.