SYNTHES HEMOSTATIC BONE PUTTY (HBP)

Wax, Bone

SYNTHES USA PRODUCTS, LLC

The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Synthes Hemostatic Bone Putty (hbp).

Pre-market Notification Details

Device IDK103822
510k NumberK103822
Device Name:SYNTHES HEMOSTATIC BONE PUTTY (HBP)
ClassificationWax, Bone
Applicant SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. West Chester,  PA  19380
ContactJeffrey L Dow
CorrespondentJeffrey L Dow
SYNTHES USA PRODUCTS, LLC 1230 WILSON BLVD. West Chester,  PA  19380
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2011-05-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.