Exactech® Equinoxe® Stemless Humeral Components

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Exactech, Inc.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech® Equinoxe® Stemless Humeral Components.

Pre-market Notification Details

• Device ID: K192097
• 510k Number: K192097
• Device Name: Exactech® Equinoxe® Stemless Humeral Components
• Classification: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• Applicant: Exactech, Inc. Gainsville, FL 32653
• Contact: Zach Sharrah
• Correspondent: Zach Sharrah; Exactech, Inc. 2320 NW 66th Court Gainsville, FL 32653
• Product Code: PKC
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-05
• Decision Date: 2020-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862559296	K192097	000
10885862538734	K192097	000
10885862538741	K192097	000
10885862538758	K192097	000
10885862538765	K192097	000
10885862538772	K192097	000
10885862539243	K192097	000
10885862539250	K192097	000
10885862541857	K192097	000
10885862542106	K192097	000
10885862538710	K192097	000
10885862617637	K192097	000
10885862617644	K192097	000
10885862617651	K192097	000
10885862559272	K192097	000
10885862559289	K192097	000
10885862538727	K192097	000