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FDA 510(k)

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

K-Number: K181390 · 2018-09-18

ApplicantOrthoPediatrics Corp.
Decision Date2018-09-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2018-09-18 under approval number K181390. 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 5.5/6.0 Spine System, Response 4.5/5.0 Spine System?

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K181390.

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

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System received FDA 510(k) clearance on 2018-09-18, under approval number K181390.

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

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

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

The FDA product code for Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine 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)

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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