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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K180610
Device Name Geister retractor for neuro - and spine surgery
Applicant
Geister Medizintechnik GmbH
Forhenstrasse 2
Tuttlingen,  DE 78532
Applicant Contact Christian Grotzinger
Correspondent
Geister Medizintechnik GmbH
Forhenstrasse 2
Tuttlingen,  DE 78532
Correspondent Contact Christian Grotzinger
Regulation Number882.4800
Classification Product Code
GZT  
Date Received03/08/2018
Decision Date 08/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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