SYNTHES CANNULATED ANGLE BLADE PLATE

Appliance, Fixation, Nail/blade/plate Combination, Single Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cannulated Angle Blade Plate.

Pre-market Notification Details

Device IDK954289
510k NumberK954289
Device Name:SYNTHES CANNULATED ANGLE BLADE PLATE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Single Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTW  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-14
Decision Date1995-11-24

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