EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Cemented Total Knee System, Tibial Components.

Pre-market Notification Details

• Device ID: K933610
• 510k Number: K933610
• Device Name: EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609
• Contact: Timothy J Seese
• Correspondent: Timothy J Seese; EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-07-27
• Decision Date: 1995-01-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862043986	K933610	000
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