SPECTRON EF ACETABULAR COMPONENT

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

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Spectron Ef Acetabular Component.

Pre-market Notification Details

Device IDK874619
510k NumberK874619
Device Name:SPECTRON EF ACETABULAR COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-09
Decision Date1988-02-17

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