ARROW Humeral Stems Size 6 And 16

Shoulder Prosthesis, Reverse Configuration

FOURNITURES HOSPITALIERES INDUSTRIE

The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Arrow Humeral Stems Size 6 And 16.

Pre-market Notification Details

• Device ID: K150568
• 510k Number: K150568
• Device Name: ARROW Humeral Stems Size 6 And 16
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000
• Contact: Patricia Donnard
• Correspondent: Patricia Donnard; FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-06
• Decision Date: 2015-10-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03661489673573	K150568	000
03661489673566	K150568	000
03661489662218	K150568	000
03661489641022	K150568	000
03661489641008	K150568	000