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FDA 510(k)

RESPONSE™ Rib and Pelvic System

K-Number: K233105 · 2024-01-20

ApplicantOrthoPediatrics Corp.
Decision Date2024-01-20
Product CodeMDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESPONSE™ Rib and Pelvic System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2024-01-20 under 510(k) number K233105. The device is classified under product code MDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE™ Rib and Pelvic System?

RESPONSE™ Rib and Pelvic System is a medical device that received FDA 510(k) clearance on 2024-01-20. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K233105.

When did RESPONSE™ Rib and Pelvic System receive FDA 510(k) clearance?

RESPONSE™ Rib and Pelvic System received FDA 510(k) clearance on 2024-01-20, under 510(k) number K233105.

Who is the listed applicant for RESPONSE™ Rib and Pelvic System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPONSE™ Rib and Pelvic System?

The FDA product code for RESPONSE™ Rib and Pelvic System is MDI.

Other records listing OrthoPediatrics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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