SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Dorsal Distal Radius Plate (ddrp) System.

Pre-market Notification Details

Device IDK962616
510k NumberK962616
Device Name:SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-03
Decision Date1996-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679401968960 K962616 000

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