SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Trochanter Stabilization Plate For Dhs.

Pre-market Notification Details

Device IDK000972
510k NumberK000972
Device Name:SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-27
Decision Date2000-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679281870S0 K000972 000
H6792818700 K000972 000

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