SYNTHES HEMOSTATIC BONE PUTTY

Wax, Bone

SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION

The following data is part of a premarket notification filed by Synthes (usa) Products Llc/norian Corporation with the FDA for Synthes Hemostatic Bone Putty.

Pre-market Notification Details

Device IDK113079
510k NumberK113079
Device Name:SYNTHES HEMOSTATIC BONE PUTTY
ClassificationWax, Bone
Applicant SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION 1230 Wilson Dr West Chester,  PA  19380
ContactJeffrey L Dow
CorrespondentJeffrey L Dow
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION 1230 Wilson Dr West Chester,  PA  19380
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-17
Decision Date2011-12-13
Summary:summary

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