CoreLink® M3 Stand-Alone Anterior Lumbar System
K-Number: K180814 · 2018-08-10
ApplicantCorelink, LLC
Decision Date2018-08-10
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CoreLink® M3 Stand-Alone Anterior Lumbar System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2018-08-10 under approval number K180814. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CoreLink® M3 Stand-Alone Anterior Lumbar System?
CoreLink® M3 Stand-Alone Anterior Lumbar System is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Corelink, LLC. The 510(k) number is K180814.
When was CoreLink® M3 Stand-Alone Anterior Lumbar System approved by the FDA?
CoreLink® M3 Stand-Alone Anterior Lumbar System received FDA 510(k) clearance on 2018-08-10, under approval number K180814.
What company makes CoreLink® M3 Stand-Alone Anterior Lumbar System?
CoreLink® M3 Stand-Alone Anterior Lumbar System is manufactured by Corelink, LLC.
What is the FDA product code for CoreLink® M3 Stand-Alone Anterior Lumbar System?
The FDA product code for CoreLink® M3 Stand-Alone Anterior Lumbar System is OVD.
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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.