Harvey(R) Surgical Assistant

Orthopedic Stereotaxic Instrument

OrthAlign Inc

The following data is part of a premarket notification filed by Orthalign Inc with the FDA for Harvey(r) Surgical Assistant.

Pre-market Notification Details

Device IDK200892
510k NumberK200892
Device Name:Harvey(R) Surgical Assistant
ClassificationOrthopedic Stereotaxic Instrument
Applicant OrthAlign Inc 120 Columbia Suite 500 Aliso Viejo,  CA  92656
ContactKaryl Haskell
CorrespondentKaryl Haskell
OrthAlign Inc 120 Columbia Suite 500 Aliso Viejo,  CA  92656
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-03
Decision Date2020-06-18

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