SCHWABE RADIUS PLATES

Plate, Fixation, Bone

LINK AMERICA, INC.

The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Schwabe Radius Plates.

Pre-market Notification Details

Device IDK914803
510k NumberK914803
Device Name:SCHWABE RADIUS PLATES
ClassificationPlate, Fixation, Bone
Applicant LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor,  NJ  07936
ContactMr E Schussler
CorrespondentMr E Schussler
LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor,  NJ  07936
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-24
Decision Date1992-04-28

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