PELVIC RADIUS PLATE

Plate, Fixation, Bone

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Pelvic Radius Plate.

Pre-market Notification Details

Device IDK936233
510k NumberK936233
Device Name:PELVIC RADIUS PLATE
ClassificationPlate, Fixation, Bone
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis,  TN  38116
ContactThomas L Craig
CorrespondentThomas L Craig
SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis,  TN  38116
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-29
Decision Date1994-08-01

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