GENESIS UNICOMPARTMENTAL KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 Unicompartmental Knee System.

Pre-market Notification Details

Device IDK912735
510k NumberK912735
Device Name:GENESIS UNICOMPARTMENTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-20
Decision Date1991-12-27

NIH GUDID Devices

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