DASH KNEE

Orthopedic Stereotaxic Instrument

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Dash Knee.

Pre-market Notification Details

Device IDK102251
510k NumberK102251
Device Name:DASH KNEE
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-09
Decision Date2011-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481006815 K102251 000

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