REVISION KNEE SYSTEM

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

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Revision Knee System.

Pre-market Notification Details

• Device ID: K041106
• 510k Number: K041106
• Device Name: REVISION KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Kim Kelly
• Correspondent: Kim Kelly; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-28
• Decision Date: 2004-07-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010544360	K041106	000
03596010545237	K041106	000
03596010545220	K041106	000
03596010545213	K041106	000
03596010545190	K041106	000
03596010545176	K041106	000
03596010545169	K041106	000
03596010545152	K041106	000
03596010545145	K041106	000
03596010545244	K041106	000
03596010545251	K041106	000
03596010545343	K041106	000
03596010545336	K041106	000
03596010545329	K041106	000
03596010545312	K041106	000
03596010545305	K041106	000
03596010545282	K041106	000
03596010545275	K041106	000
03596010545268	K041106	000
03596010545138	K041106	000
03596010545121	K041106	000
03596010544483	K041106	000
03596010544452	K041106	000
03596010544445	K041106	000
03596010544438	K041106	000
03596010544421	K041106	000
03596010544391	K041106	000
03596010544384	K041106	000
03596010544377	K041106	000
03596010544506	K041106	000
03596010544988	K041106	000
03596010545091	K041106	000
03596010545084	K041106	000
03596010545046	K041106	000
03596010545039	K041106	000
03596010545022	K041106	000
03596010545015	K041106	000
03596010545008	K041106	000
03596010544995	K041106	000
03596010551917	K041106	000
03596010551924	K041106	000
03596010551931	K041106	000
03596010545442	K041106	000
03596010545435	K041106	000
03596010545381	K041106	000
03596010545299	K041106	000
03596010545206	K041106	000
03596010545183	K041106	000
03596010545114	K041106	000
03596010545107	K041106	000
03596010551825	K041106	000
03596010551832	K041106	000
00885556062661	K041106	000
00885556062449	K041106	000
00885556062142	K041106	000
00885556061787	K041106	000
00885556061145	K041106	000
00885556052891	K041106	000
00885556052662	K041106	000
03596010551962	K041106	000
03596010545077	K041106	000
03596010545060	K041106	000
03596010545411	K041106	000
03596010545404	K041106	000
03596010545398	K041106	000
03596010545374	K041106	000
03596010545367	K041106	000
03596010545350	K041106	000
03596010551955	K041106	000
03596010551948	K041106	000
03596010545428	K041106	000
03596010544407	K041106	000
03596010545053	K041106	000
03596010544971	K041106	000
03596010544964	K041106	000
03596010544513	K041106	000
03596010544490	K041106	000
03596010544476	K041106	000
03596010544469	K041106	000
03596010544414	K041106	000
00885556062982	K041106	000