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FDA 510(k)

RESPONSE Navigation Instruments

K-Number: K203573 · 2021-02-04

ApplicantOrthoPediatrics Corp.
Decision Date2021-02-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESPONSE Navigation Instruments is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2021-02-04 under approval number K203573. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE Navigation Instruments?

RESPONSE Navigation Instruments is a medical device that received FDA 510(k) clearance on 2021-02-04. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K203573.

When was RESPONSE Navigation Instruments approved by the FDA?

RESPONSE Navigation Instruments received FDA 510(k) clearance on 2021-02-04, under approval number K203573.

What company makes RESPONSE Navigation Instruments?

RESPONSE Navigation Instruments is manufactured by OrthoPediatrics Corp..

What is the FDA product code for RESPONSE Navigation Instruments?

The FDA product code for RESPONSE Navigation Instruments is OLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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