SYMMETRIC TOTAL KNEE SYSTEM

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

SIGNAL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Signal Medical Corporation with the FDA for Symmetric Total Knee System.

Pre-market Notification Details

• Device ID: K080199
• 510k Number: K080199
• Device Name: SYMMETRIC TOTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SIGNAL MEDICAL CORPORATION 1000 DES PERES RD. SUITE 140 St. Louis, MO 63131
• Contact: Brian Katerberg
• Correspondent: Brian Katerberg; SIGNAL MEDICAL CORPORATION 1000 DES PERES RD. SUITE 140 St. Louis, MO 63131
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-25
• Decision Date: 2008-07-03
• Summary: summary

NIH GUDID Devices

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