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FDA 510(k)

Comprehensive® Reverse Shoulder

K-Number: K193373 · 2020-04-15

ApplicantBiomet, Inc.
Decision Date2020-04-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive® Reverse Shoulder is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2020-04-15 under approval number K193373. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comprehensive® Reverse Shoulder?

Comprehensive® Reverse Shoulder is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Biomet, Inc.. The 510(k) number is K193373.

When was Comprehensive® Reverse Shoulder approved by the FDA?

Comprehensive® Reverse Shoulder received FDA 510(k) clearance on 2020-04-15, under approval number K193373.

What company makes Comprehensive® Reverse Shoulder?

Comprehensive® Reverse Shoulder is manufactured by Biomet, Inc..

What is the FDA product code for Comprehensive® Reverse Shoulder?

The FDA product code for Comprehensive® Reverse Shoulder is PHX.

Related Clinical Trials

NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT06788717 MDR - Comprehensive Primary Revision Stems PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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