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FDA 510(k)

Arthrex Univers Revers Shoulder Prosthesis System

K-Number: K161782 · 2016-11-21

ApplicantArthrex, Inc.
Decision Date2016-11-21
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Shoulder Prosthesis System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-11-21 under approval number K161782. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Univers Revers Shoulder Prosthesis System?

Arthrex Univers Revers Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Arthrex, Inc.. The 510(k) number is K161782.

When was Arthrex Univers Revers Shoulder Prosthesis System approved by the FDA?

Arthrex Univers Revers Shoulder Prosthesis System received FDA 510(k) clearance on 2016-11-21, under approval number K161782.

What company makes Arthrex Univers Revers Shoulder Prosthesis System?

Arthrex Univers Revers Shoulder Prosthesis System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers Shoulder Prosthesis System?

The FDA product code for Arthrex Univers Revers Shoulder Prosthesis System is HSD.

Related Clinical Trials

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING NCT05124652 An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters K160461Arthrex iBalance BiCompartmental Arthroplasty System

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Related Devices (Code: HSD)

K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC K221232Univers Revers Humeral Cup ImplantArthrex, 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.

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