ARROW Short Stem Humeral System

Shoulder Prosthesis, Reverse Configuration

FH Industrie

The following data is part of a premarket notification filed by Fh Industrie with the FDA for Arrow Short Stem Humeral System.

Pre-market Notification Details

• Device ID: K202024
• 510k Number: K202024
• Device Name: ARROW Short Stem Humeral System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: FH Industrie 6 Rue Nobel, Zi De Kernevez Quimper, FR 29000
• Contact: Patricia Donnard
• Correspondent: Christine Scifert; MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-22
• Decision Date: 2021-11-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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