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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K190179
Device Name SAHARA Stabilization System
Applicant
K2M, Inc.
600 Hope Parkway SE
Leesburg,  VA  20175
Applicant Contact Oonagh Lahiff
Correspondent
Stryker
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Renee Norby
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received02/01/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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