Exactech® Equinoxe® Laser Cage Glenoid

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Exactech, Inc.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech® Equinoxe® Laser Cage Glenoid.

Pre-market Notification Details

• Device ID: K212356
• 510k Number: K212356
• Device Name: Exactech® Equinoxe® Laser Cage Glenoid
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL 32653
• Contact: Kenneth C. Maxwell
• Correspondent: Kenneth C. Maxwell; Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL 32653
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-29
• Decision Date: 2022-03-04