MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modofocation To Synthes Ankle Arthrodesis Plates.

Pre-market Notification Details

Device IDK022255
510k NumberK022255
Device Name:MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-12
Decision Date2002-07-25
Summary:summary

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