REFLECTION ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Reflection Acetabular Component.

Pre-market Notification Details

Device IDK932755
510k NumberK932755
Device Name:REFLECTION ACETABULAR COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactThomas Craig
CorrespondentThomas Craig
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-21
Decision Date1994-05-06

NIH GUDID Devices

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