GENESIS CONSTRAINED SYSTEM (GCS)

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 Constrained System (gcs).

Pre-market Notification Details

Device IDK952271
510k NumberK952271
Device Name:GENESIS CONSTRAINED SYSTEM (GCS)
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactThomas L Craig
CorrespondentThomas L Craig
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-15
Decision Date1995-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010184979 K952271 000
03596010184726 K952271 000
03596010184757 K952271 000
03596010184764 K952271 000
03596010184856 K952271 000
03596010184733 K952271 000
03596010184740 K952271 000
03596010184788 K952271 000
03596010184795 K952271 000
03596010184801 K952271 000
03596010184665 K952271 000

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