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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
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Applicant Contact ALEXANDER SCHWIERSCH
Correspondent
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Correspondent 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 Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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