ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210

Orthopedic Stereotaxic Instrument

AESCULAP IMPLANT SYSTEM, INC.

The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Orthopilot Next Generation-uka Software, Model Fs210.

Pre-market Notification Details

Device IDK090375
510k NumberK090375
Device Name:ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
ClassificationOrthopedic Stereotaxic Instrument
Applicant AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa M Boyle
CorrespondentLisa M Boyle
AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-17
Decision Date2009-06-23
Summary:summary

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