AEQUALIS REVERSED ADAPTER

Shoulder Prosthesis, Reverse Configuration

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Reversed Adapter.

Pre-market Notification Details

• Device ID: K071948
• 510k Number: K071948
• Device Name: AEQUALIS REVERSED ADAPTER
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334
• Contact: Mireille Lemery
• Correspondent: Mireille Lemery; TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-13
• Decision Date: 2007-10-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700434023190	K071948	000
03700434023183	K071948	000
03700434023176	K071948	000