OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++

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 9mm Cruciate Retaining Tibial Insert, Slope ++.

Pre-market Notification Details

• Device ID: K082022
• 510k Number: K082022
• Device Name: OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Graham Cuthbert
• Correspondent: Graham Cuthbert; 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: 2008-07-16
• Decision Date: 2008-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862041326	K082022	000
10885862041296	K082022	000
10885862041258	K082022	000
10885862041210	K082022	000
10885862041173	K082022	000