OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI

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 Optetrak Total Knee System, Hi-flex Asymmetric Posterior-stabilized Cemented Femoral Components, Hi-flex Posterior-stabi.

Pre-market Notification Details

• Device ID: K033883
• 510k Number: K033883
• Device Name: OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-15
• Decision Date: 2004-02-13
• Summary: summary

NIH GUDID Devices

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