RESPONSE Navigation Instruments

Orthopedic Stereotaxic Instrument

OrthoPediatrics, Corp.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Response Navigation Instruments.

Pre-market Notification Details

Device IDK203573
510k NumberK203573
Device Name:RESPONSE Navigation Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw,  IN  46582
ContactYan Li
CorrespondentYan Li
OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw,  IN  46582
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-02-04

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