InterOss

Bone Grafting Material, Animal Source

SigmaGraft, Inc

The following data is part of a premarket notification filed by Sigmagraft, Inc with the FDA for Inteross.

Pre-market Notification Details

Device IDK151209
510k NumberK151209
Device Name:InterOss
ClassificationBone Grafting Material, Animal Source
Applicant SigmaGraft, Inc 335 N. Puente St. Unit A Brea,  CA  92821
ContactMegan Holden
CorrespondentMegan Holden
SigmaGraft, Inc 335 N. Puente St. Unit A Brea,  CA  92821
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-06
Decision Date2015-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855318006325 K151209 000
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00852072007100 K151209 000
00852072007094 K151209 000
00852072007209 K151209 000

Trademark Results [InterOss]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEROSS
INTEROSS
85789028 4456430 Live/Registered
SigmaGraft, Inc.
2012-11-28

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