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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 K193307
Device Name HIP7
Applicant
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Applicant Contact Cherita James
Correspondent
Msquared Associates, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Cherita James
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/29/2019
Decision Date 06/02/2020
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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