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FDA 510(k)

RESPONSE 5.5/6.0 Cannulated Screw System

K-Number: K222105 · 2023-03-23

ApplicantOrthoPediatrics Corp.
Decision Date2023-03-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESPONSE 5.5/6.0 Cannulated Screw System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2023-03-23 under approval number K222105. 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 5.5/6.0 Cannulated Screw System?

RESPONSE 5.5/6.0 Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K222105.

When was RESPONSE 5.5/6.0 Cannulated Screw System approved by the FDA?

RESPONSE 5.5/6.0 Cannulated Screw System received FDA 510(k) clearance on 2023-03-23, under approval number K222105.

What company makes RESPONSE 5.5/6.0 Cannulated Screw System?

RESPONSE 5.5/6.0 Cannulated Screw System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for RESPONSE 5.5/6.0 Cannulated Screw System?

The FDA product code for RESPONSE 5.5/6.0 Cannulated Screw System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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