KLASSIC KNEE SYSTEM

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

TOTAL JOINT ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Knee System.

Pre-market Notification Details

• Device ID: K112906
• 510k Number: K112906
• Device Name: KLASSIC KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: TOTAL JOINT ORTHOPEDICS, INC. 755 N. MATHILDA AVENUE Sunnyvale, CA 94085
• Contact: Heather Lake
• Correspondent: Heather Lake; TOTAL JOINT ORTHOPEDICS, INC. 755 N. MATHILDA AVENUE Sunnyvale, CA 94085
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-03
• Decision Date: 2012-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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