FDA 510(k)

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System

K-Number: K193100 · 2020-03-24

Decision Date2020-03-24

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2020-03-24 under approval number K193100. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System?

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System is a medical device that received FDA 510(k) clearance on 2020-03-24. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K193100.

When was RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System approved by the FDA?

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System received FDA 510(k) clearance on 2020-03-24, under approval number K193100.

What company makes RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System?

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System?

The FDA product code for RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System is NKB.

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Official Source

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