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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 a medical device manufactured by Aptis Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under approval 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. It is manufactured by Aptis Medical, LLC. The 510(k) number is K190599.

When was Aptis Medical Distal Radio Ulnar Joint Implant approved by the FDA?

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

What company makes Aptis Medical Distal Radio Ulnar Joint Implant?

Aptis Medical Distal Radio Ulnar Joint Implant is manufactured by Aptis Medical, LLC.

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.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 41966215 Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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