Exactech® Equinoxe® Reverse Shoulder Glenospheres

Shoulder Prosthesis, Reverse Configuration

Exactech, Inc

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

Pre-market Notification Details

• Device ID: K193098
• 510k Number: K193098
• Device Name: Exactech® Equinoxe® Reverse Shoulder Glenospheres
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Exactech, Inc 2320 NW 66th Court Gainesville, FL 32653
• Contact: Zach Sharrah
• Correspondent: Zach Sharrah; Exactech, Inc 2320 NW 66th Court Gainesville, FL 32653
• Product Code: PHX
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-07
• Decision Date: 2020-02-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862622198	K193098	000
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