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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 K122011
Device Name NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
Original Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen,  DE 85622
Original Contact alexander schwiersch
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/09/2012
Decision Date 11/15/2012
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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