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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 K181890
Device Name Brainlab Compatible K2M Navigation Instruments
Applicant
K2m
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Nancy Giezen
Correspondent
K2m
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Nancy Giezen
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/13/2018
Decision Date 11/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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