Humelock II Reversible Shoulder System

Shoulder Prosthesis, Reverse Configuration

FX SOLUTIONS

The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Ii Reversible Shoulder System.

Pre-market Notification Details

• Device ID: K150488
• 510k Number: K150488
• Device Name: Humelock II Reversible Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440
• Contact: Jean-jacques Martin
• Correspondent: Cheryl Hastings; FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-25
• Decision Date: 2015-11-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03701037302583	K150488	000
03701037302408	K150488	000
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