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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K201006
Device Name K2M Navigation Instruments
Applicant
K2M, Inc.
600 Hope Parkway SE
Leesburg,  VA  20175
Applicant Contact Oonagh Lahiff
Correspondent
Stryker
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Megan Callanan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/17/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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