TC-PLUS SOLUTION KNEE

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

PLUS ORTHOPEDICS

The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Tc-plus Solution Knee.

Pre-market Notification Details

• Device ID: K000666
• 510k Number: K000666
• Device Name: TC-PLUS SOLUTION KNEE
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1194
• Contact: Hartmut Loch
• Correspondent: Hartmut Loch; PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1194
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-28
• Decision Date: 2000-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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