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FDA 510(k)

TRUMATCH Personalized Solutions

K-Number: K193540 · 2020-06-16

ApplicantDePuy Orthopaedics, Inc.
Decision Date2020-06-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUMATCH Personalized Solutions is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-06-16 under approval number K193540. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUMATCH Personalized Solutions?

TRUMATCH Personalized Solutions is a medical device that received FDA 510(k) clearance on 2020-06-16. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K193540.

When was TRUMATCH Personalized Solutions approved by the FDA?

TRUMATCH Personalized Solutions received FDA 510(k) clearance on 2020-06-16, under approval number K193540.

What company makes TRUMATCH Personalized Solutions?

TRUMATCH Personalized Solutions is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for TRUMATCH Personalized Solutions?

The FDA product code for TRUMATCH Personalized Solutions is JWH.

Related Clinical Trials

NCT07590349 Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting NOT_YET_RECRUITING NCT07073378 BCI@Home: Brain Computer Interface Solutions to Enable Youth Living With Severe Disabilities RECRUITING NCT07566728 ADAI - Home Care in Intelligent Environments Clinical Care Ecosystem for the Management of Home Digital Therapies Through the Use of Assistive Robots and Clinical Predictive Systems Based on Artificial Intelligence Systems COMPLETED

Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Related Devices (Code: JWH)

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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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