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FDA 510(k)

Response 5.5 Spine System

K-Number: K160466 · 2016-03-23

ApplicantOrthoPediatrics Corp.
Decision Date2016-03-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Response 5.5 Spine System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2016-03-23 under approval number K160466. 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 5.5 Spine System?

Response 5.5 Spine System is a medical device that received FDA 510(k) clearance on 2016-03-23. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K160466.

When was Response 5.5 Spine System approved by the FDA?

Response 5.5 Spine System received FDA 510(k) clearance on 2016-03-23, under approval number K160466.

What company makes Response 5.5 Spine System?

Response 5.5 Spine System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Response 5.5 Spine System?

The FDA product code for Response 5.5 Spine System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by OrthoPediatrics Corp.

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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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