ZIRCONIUM ALLOY FRMORAL HEAD

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Zirconium Alloy Frmoral Head.

Pre-market Notification Details

Device IDK914878
510k NumberK914878
Device Name:ZIRCONIUM ALLOY FRMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactTom Craig
CorrespondentTom Craig
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-30
Decision Date1992-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010502285 K914878 000
03596010502278 K914878 000
03596010502261 K914878 000
03596010502254 K914878 000
03596010502247 K914878 000
03596010502230 K914878 000
03596010502032 K914878 000
03596010502025 K914878 000
03596010502018 K914878 000

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