GENESIS II CONSTRAINED SYSTEM

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

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Genesis Ii Constrained System.

Pre-market Notification Details

• Device ID: K962137
• 510k Number: K962137
• Device Name: GENESIS II CONSTRAINED SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-06-03
• Decision Date: 1996-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556045282	K962137	000
00885556419786	K962137	000
00885556419830	K962137	000
00885556419885	K962137	000
00885556419939	K962137	000
00885556419984	K962137	000
00885556420034	K962137	000
00885556420089	K962137	000
00885556420133	K962137	000
00885556420188	K962137	000
00885556420232	K962137	000
00885556420287	K962137	000
00885556420331	K962137	000
00885556420386	K962137	000
00885556084335	K962137	000
00885556084281	K962137	000
00885556084236	K962137	000
00885556045503	K962137	000
00885556046067	K962137	000
00885556046944	K962137	000
00885556051498	K962137	000
00885556083789	K962137	000
00885556083833	K962137	000
00885556083888	K962137	000
00885556083932	K962137	000
00885556083987	K962137	000
00885556084038	K962137	000
00885556084083	K962137	000
00885556084137	K962137	000
00885556084182	K962137	000
00885556420430	K962137	000
00885556420485	K962137	000
03596010210074	K962137	000
03596010210081	K962137	000
03596010210098	K962137	000
03596010210104	K962137	000
03596010210111	K962137	000
03596010210128	K962137	000
03596010210135	K962137	000
03596010210142	K962137	000
03596010210159	K962137	000
03596010210166	K962137	000
03596010555809	K962137	000
03596010555816	K962137	000
03596010555823	K962137	000
03596010210067	K962137	000
03596010210050	K962137	000
03596010210043	K962137	000
00885556590942	K962137	000
00885556590959	K962137	000
00885556590966	K962137	000
03596010209948	K962137	000
03596010209955	K962137	000
03596010209962	K962137	000
03596010209979	K962137	000
03596010209986	K962137	000
03596010209993	K962137	000
03596010210005	K962137	000
03596010210012	K962137	000
03596010210029	K962137	000
03596010210036	K962137	000
03596010555830	K962137	000