FDA 510(k)

Contour Knee

K-Number: K223429 · 2023-01-13

Decision Date2023-01-13

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Contour Knee is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2023-01-13 under approval number K223429. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Contour Knee?

Contour Knee is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K223429.

When was Contour Knee approved by the FDA?

Contour Knee received FDA 510(k) clearance on 2023-01-13, under approval number K223429.

What company makes Contour Knee?

Contour Knee is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for Contour Knee?

The FDA product code for Contour Knee is MOS.

Other Devices by Quality Electrodynamics, LLC

K16262316ch T/R Hand Wrist Coil K162966TxRx Knee 15 Flare MR Coil 1.5T K163066TxRx Knee 15 Flare MR Coil 3.0T K16202916ch T/R Knee Coil K16119316ch Tx/Rx Knee SPEEDER K173446Contour 24

View all 14 devices →

Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

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.