NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP

Orthopedic Stereotaxic Instrument

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Navigation Software Hip-universal; Navigation Software Hip Thr-aesculap.

Pre-market Notification Details

Device IDK122011
510k NumberK122011
Device Name:NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
ClassificationOrthopedic Stereotaxic Instrument
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactAlexander Schwiersch
CorrespondentAlexander Schwiersch
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-09
Decision Date2012-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481005368 K122011 000
04056481002077 K122011 000
04056481002060 K122011 000
04056481002053 K122011 000
04056481002046 K122011 000
04056481002022 K122011 000
04056481002008 K122011 000
04056481001995 K122011 000
04056481001957 K122011 000
04056481001889 K122011 000
04056481001872 K122011 000
04056481002084 K122011 000
04056481002091 K122011 000
04056481003586 K122011 000
04056481003562 K122011 000
04056481003494 K122011 000
04056481003470 K122011 000
04056481003210 K122011 000
04056481002688 K122011 000
04056481002671 K122011 000
04056481002657 K122011 000
04056481002206 K122011 000
04056481002107 K122011 000
04056481122805 K122011 000

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