SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K-Number: K180665 · 2018-11-28
ApplicantK2m, LLC
Decision Date2018-11-28
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is a medical device manufactured by K2m, LLC. It received FDA 510(k) clearance on 2018-11-28 under approval number K180665. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by K2m, LLC. The 510(k) number is K180665.
When was SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System approved by the FDA?
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System received FDA 510(k) clearance on 2018-11-28, under approval number K180665.
What company makes SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is manufactured by K2m, LLC.
What is the FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?
The FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is MQP.
Related Devices (Code: MQP)
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K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.
K172323Omnia Medical VBROmnia Medical, LLC
K171686Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine
K171704CAPRI Corpectomy Cage SystemK2m
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.