EQUINOXE REVERSE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K063569
• 510k Number: K063569
• Device Name: EQUINOXE REVERSE SHOULDER SYSTEM
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Amnon Talmor
• Correspondent: Amnon Talmor; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-29
• Decision Date: 2007-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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