Yukon OCT Spinal System

Posterior Cervical Screw System

K2M, Inc.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Yukon Oct Spinal System.

Pre-market Notification Details

Device IDK193129
510k NumberK193129
Device Name:Yukon OCT Spinal System
ClassificationPosterior Cervical Screw System
Applicant K2M, Inc. 600 Hope Parkway SE Leesburg,  VA  20175
ContactOonagh Lahiff
CorrespondentAli Khan
Stryker 59 Route 17 Allendale,  NJ  07401
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-02-07

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