Klassic Knee System Tibial Inserts, PS-Max

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 Tibial Inserts, Ps-max.

Pre-market Notification Details

• Device ID: K202740
• 510k Number: K202740
• Device Name: Klassic Knee System Tibial Inserts, PS-Max
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Contact: Chris Weaber
• Correspondent: Chris Weaber; Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-18
• Decision Date: 2020-10-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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