OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)

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 Size 0/1 Delta (line Extension).

Pre-market Notification Details

• Device ID: K011976
• 510k Number: K011976
• Device Name: OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Gary J Miller
• Correspondent: Gary J 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: 2001-06-25
• Decision Date: 2001-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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