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FDA 510(k)

OvertureTi Knee Resurfacing SystemTM

K-Number: K242746 · 2024-10-07

ApplicantOverture Orthopaedics
Decision Date2024-10-07
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OvertureTi Knee Resurfacing SystemTM is a medical device manufactured by Overture Orthopaedics. It received FDA 510(k) clearance on 2024-10-07 under approval number K242746. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OvertureTi Knee Resurfacing SystemTM?

OvertureTi Knee Resurfacing SystemTM is a medical device that received FDA 510(k) clearance on 2024-10-07. It is manufactured by Overture Orthopaedics. The 510(k) number is K242746.

When was OvertureTi Knee Resurfacing SystemTM approved by the FDA?

OvertureTi Knee Resurfacing SystemTM received FDA 510(k) clearance on 2024-10-07, under approval number K242746.

What company makes OvertureTi Knee Resurfacing SystemTM?

OvertureTi Knee Resurfacing SystemTM is manufactured by Overture Orthopaedics.

What is the FDA product code for OvertureTi Knee Resurfacing SystemTM?

The FDA product code for OvertureTi Knee Resurfacing SystemTM is HSX.

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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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