Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

K-Number: K172502 · 2018-01-03

ApplicantBiomet Manufacturing Corp
Decision Date2018-01-03
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2018-01-03 under approval number K172502. 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 Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate?

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate is a medical device that received FDA 510(k) clearance on 2018-01-03. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K172502.

When was Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate approved by the FDA?

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate received FDA 510(k) clearance on 2018-01-03, under approval number K172502.

What company makes Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate?

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate is manufactured by Biomet Manufacturing Corp.

What is the FDA product code for Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate?

The FDA product code for Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate is PHX.

Related Clinical Trials

NCT07614607 Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial ACTIVE_NOT_RECRUITING NCT06668246 Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS) COMPLETED NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT07587294 Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction NOT_YET_RECRUITING NCT07580547 Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes NOT_YET_RECRUITING

Other Devices by Biomet Manufacturing Corp

K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) K153558Ventix Suture Anchor K152262Ventix Knotless Anchors K152868ExpressBraid Graft Manipulation K153398Comprehensive SRS/Nexel Elbow K163651ExpressBraid Graft Manipulation

View all 16 devices →

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.

↑