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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 the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) 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. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K223429.

When did Contour Knee receive FDA 510(k) clearance?

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

Who is the listed applicant for Contour Knee?

The FDA 510(k) record lists Quality Electrodynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Contour Knee?

The FDA product code for Contour Knee is MOS.

Other records listing Quality Electrodynamics, LLC 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.

View all 17 devices →

Related Devices (Code: MOS)

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.

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.