CoLink NeoFuse Plating System
K-Number: K213069 · 2021-12-13
ApplicantIn2bones USA, LLC
Decision Date2021-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CoLink NeoFuse Plating System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2021-12-13 under approval number K213069. 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 NeoFuse Plating System?
CoLink NeoFuse Plating System is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by In2bones USA, LLC. The 510(k) number is K213069.
When was CoLink NeoFuse Plating System approved by the FDA?
CoLink NeoFuse Plating System received FDA 510(k) clearance on 2021-12-13, under approval number K213069.
What company makes CoLink NeoFuse Plating System?
CoLink NeoFuse Plating System is manufactured by In2bones USA, LLC.
What is the FDA product code for CoLink NeoFuse Plating System?
The FDA product code for CoLink NeoFuse 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.