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FDA 510(k)

Aptis Medical Distal Radio Ulnar Joint Implant

K-Number: K190599 · 2019-05-03

ApplicantAptis Medical, LLC
Decision Date2019-05-03
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aptis Medical Distal Radio Ulnar Joint Implant is the device name listed in this FDA 510(k) record. The listed applicant is Aptis Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190599. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptis Medical Distal Radio Ulnar Joint Implant?

Aptis Medical Distal Radio Ulnar Joint Implant is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Aptis Medical, LLC. The 510(k) number is K190599.

When did Aptis Medical Distal Radio Ulnar Joint Implant receive FDA 510(k) clearance?

Aptis Medical Distal Radio Ulnar Joint Implant received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190599.

Who is the listed applicant for Aptis Medical Distal Radio Ulnar Joint Implant?

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

What is the FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant?

The FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant is KXE.

Related Clinical Trials

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.

NCT05796908Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.RECRUITING

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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