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FDA 510(k)

ARROW Short Stem Humeral System

K-Number: K202024 · 2021-11-30

ApplicantFH Industrie
Decision Date2021-11-30
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARROW Short Stem Humeral System is a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2021-11-30 under approval number K202024. 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 ARROW Short Stem Humeral System?

ARROW Short Stem Humeral System is a medical device that received FDA 510(k) clearance on 2021-11-30. It is manufactured by FH Industrie. The 510(k) number is K202024.

When was ARROW Short Stem Humeral System approved by the FDA?

ARROW Short Stem Humeral System received FDA 510(k) clearance on 2021-11-30, under approval number K202024.

What company makes ARROW Short Stem Humeral System?

ARROW Short Stem Humeral System is manufactured by FH Industrie.

What is the FDA product code for ARROW Short Stem Humeral System?

The FDA product code for ARROW Short Stem Humeral System is PHX.

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Other Devices by FH Industrie

K200127TELEGRAPH® EVOLUTION Humeral Nailing System K201928e-Ortho Shoulder Software K220758e-Ortho Shoulder Software v1.1 K232226ARROW Off-Centred Humeral Insert K242253JARVIS Glenoid Reverse Shoulder Prosthesis K253345JARVIS Diaphyseal Stem Standard

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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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