Orthopedic Stereotaxic Instrument

Orthokey Italia S.r.l.

The following data is part of a premarket notification filed by Orthokey Italia S.r.l. with the FDA for Perseus.

Pre-market Notification Details

Device IDK192653
510k NumberK192653
Device Name:Perseus
ClassificationOrthopedic Stereotaxic Instrument
Applicant Orthokey Italia S.r.l. Piazza Nazioni Unite, 15 Carrara,  IT 54033
ContactCristiano Paggetti
CorrespondentGuido Bonapace
Isemed Srl Via P. Togliatti, 19/X Imola,  IT 40026
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-09-09

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