BOND APATITE

Bone Grafting Material, Synthetic

AUGMA BIOMATERIALS, LTD.

The following data is part of a premarket notification filed by Augma Biomaterials, Ltd. with the FDA for Bond Apatite.

Pre-market Notification Details

Device IDK121177
510k NumberK121177
Device Name:BOND APATITE
ClassificationBone Grafting Material, Synthetic
Applicant AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
ContactKevin A Thomas
CorrespondentKevin A Thomas
AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-18
Decision Date2013-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290108992533 K121177 000
07290108992526 K121177 000

Trademark Results [BOND APATITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOND APATITE
BOND APATITE
85450734 4495220 Live/Registered
Augma Biomaterials
2011-10-19

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