BOND BONE

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 Bone.

Pre-market Notification Details

Device IDK083858
510k NumberK083858
Device Name:BOND BONE
ClassificationBone Grafting Material, Synthetic
Applicant AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego,  CA  92130
ContactDavid J Collette
CorrespondentDavid J Collette
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 Received2008-12-24
Decision Date2009-03-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290014838014 K083858 000
17290014838007 K083858 000
07290014838055 K083858 000
07290014838062 K083858 000

Trademark Results [BOND BONE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOND BONE
BOND BONE
77552842 3920202 Live/Registered
MIS IMPLANTS TECHNOLOGIES LTD.
2008-08-21

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