OSTEOPAL Plus

Bone Cement

HERAEUS MEDICAL GMBH

The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Osteopal Plus.

Pre-market Notification Details

Device IDK153737
510k NumberK153737
Device Name:OSTEOPAL Plus
ClassificationBone Cement
Applicant HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim,  DE 61273
ContactAstrid Marx
CorrespondentGordon Macfarlane
ICON Plc 62 Forest Street Marlborough,  MA  01752
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-28
Decision Date2016-04-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102132603 K153737 000

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