ACHIEVE Partial Knee System
K-Number: K242307 · 2024-12-16
ApplicantIgnite Orthomotion
Decision Date2024-12-16
Product CodeNJD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ACHIEVE Partial Knee System is a medical device manufactured by Ignite Orthomotion. It received FDA 510(k) clearance on 2024-12-16 under approval number K242307. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACHIEVE Partial Knee System?
ACHIEVE Partial Knee System is a medical device that received FDA 510(k) clearance on 2024-12-16. It is manufactured by Ignite Orthomotion. The 510(k) number is K242307.
When was ACHIEVE Partial Knee System approved by the FDA?
ACHIEVE Partial Knee System received FDA 510(k) clearance on 2024-12-16, under approval number K242307.
What company makes ACHIEVE Partial Knee System?
ACHIEVE Partial Knee System is manufactured by Ignite Orthomotion.
What is the FDA product code for ACHIEVE Partial Knee System?
The FDA product code for ACHIEVE Partial Knee System is NJD.
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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.