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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 K173946
Device Name ADAPT for Gamma3
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Applicant Contact Nesli Karakaya
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach, Solothurn, Ch,  CH 2545
Correspondent Contact Nesli Karakaya
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/27/2017
Decision Date 05/02/2018
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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