CoLink PCR Plating System
K-Number: K213698 · 2022-05-27
ApplicantIn2bones USA, LLC
Decision Date2022-05-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CoLink PCR Plating System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2022-05-27 under approval number K213698. 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 PCR Plating System?
CoLink PCR Plating System is a medical device that received FDA 510(k) clearance on 2022-05-27. It is manufactured by In2bones USA, LLC. The 510(k) number is K213698.
When was CoLink PCR Plating System approved by the FDA?
CoLink PCR Plating System received FDA 510(k) clearance on 2022-05-27, under approval number K213698.
What company makes CoLink PCR Plating System?
CoLink PCR Plating System is manufactured by In2bones USA, LLC.
What is the FDA product code for CoLink PCR Plating System?
The FDA product code for CoLink PCR 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.