EXACTECH OPTETRAK UNICONDYLAR KNEE

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Optetrak Unicondylar Knee.

Pre-market Notification Details

• Device ID: K040889
• 510k Number: K040889
• Device Name: EXACTECH OPTETRAK UNICONDYLAR KNEE
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Gary Miller
• Correspondent: Gary Miller; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-05
• Decision Date: 2004-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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