CAPRI Corpectomy Cage System

Spinal Vertebral Body Replacement Device

K2M

The following data is part of a premarket notification filed by K2m with the FDA for Capri Corpectomy Cage System.

Pre-market Notification Details

Device IDK171704
510k NumberK171704
Device Name:CAPRI Corpectomy Cage System
ClassificationSpinal Vertebral Body Replacement Device
Applicant K2M 600 Hope Parkway SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M 600 Hope Parkway SE Leesburg,  VA  20175
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-08
Decision Date2017-08-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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