A200 KNEE SYSTEM

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

RENOVIS SURGICAL TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Renovis Surgical Technologies, Llc with the FDA for A200 Knee System.

Pre-market Notification Details

• Device ID: K120038
• 510k Number: K120038
• Device Name: A200 KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
• Applicant: RENOVIS SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130
• Contact: Kevin A Thomas
• Correspondent: Kevin A Thomas; RENOVIS SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130
• Product Code: OIY
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-05
• Decision Date: 2013-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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