Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly

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 - Klassic Knee Ps-post Femur; Klassic Knee Tibial Insert, Ps-post, Std Poly; Klassic Knee Tibial Insert, Ps-post, E-link Poly.

Pre-market Notification Details

• Device ID: K183596
• 510k Number: K183596
• Device Name: Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-21
• Decision Date: 2019-03-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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