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 a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2024-01-20 under approval 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. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K233105.
When was RESPONSE Rib and Pelvic System approved by the FDA?
RESPONSE Rib and Pelvic System received FDA 510(k) clearance on 2024-01-20, under approval number K233105.
What company makes RESPONSE Rib and Pelvic System?
RESPONSE Rib and Pelvic System is manufactured by OrthoPediatrics Corp..
What is the FDA product code for RESPONSE Rib and Pelvic System?
The FDA product code for RESPONSE Rib and Pelvic System is MDI.
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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.