SCHUHLI IMPLANT SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Schuhli Implant System.

Pre-market Notification Details

Device IDK954963
510k NumberK954963
Device Name:SCHUHLI IMPLANT SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-30
Decision Date1996-03-22
Summary:summary

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