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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K193129
Device Name Yukon OCT Spinal System
Applicant
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Oonagh Lahiff
Correspondent
Stryker
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact Ali Khan
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received11/12/2019
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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