PEDIPLATES

Plate, Fixation, Bone

ORTHOPEDIATRICS, CORP.

The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Pediplates.

Pre-market Notification Details

Device IDK090666
510k NumberK090666
Device Name:PEDIPLATES
ClassificationPlate, Fixation, Bone
Applicant ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw,  IN  46580
ContactGary Barnett
CorrespondentGary Barnett
ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. Warsaw,  IN  46580
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeOBT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-13
Decision Date2009-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841132108970 K090666 000
00841132113707 K090666 000
00841132113714 K090666 000
00841132113721 K090666 000
00841132113738 K090666 000
00841132113745 K090666 000
00841132113752 K090666 000
00841132113769 K090666 000
00841132113776 K090666 000
00841132113783 K090666 000
00841132113790 K090666 000
00841132113806 K090666 000
00841132113813 K090666 000
00841132113820 K090666 000
00841132113691 K090666 000
00841132113684 K090666 000
00841132108987 K090666 000
00841132108994 K090666 000
00841132109007 K090666 000
00841132109014 K090666 000
00841132109021 K090666 000
00841132109038 K090666 000
00841132109045 K090666 000
00841132109052 K090666 000
00841132109069 K090666 000
00841132109076 K090666 000
00841132109083 K090666 000
00841132109090 K090666 000
00841132109106 K090666 000
00841132113837 K090666 000
00841132113844 K090666 000
00841132114001 K090666 000
00841132114018 K090666 000
00841132114025 K090666 000
00841132114032 K090666 000
00841132114049 K090666 000
00841132114056 K090666 000
00841132114063 K090666 000
00841132114070 K090666 000
00841132114087 K090666 000
00841132114094 K090666 000
00841132114100 K090666 000
00841132114117 K090666 000
00841132114124 K090666 000
00841132113998 K090666 000
00841132113981 K090666 000
00841132113851 K090666 000
00841132113868 K090666 000
00841132113875 K090666 000
00841132113882 K090666 000
00841132113899 K090666 000
00841132113905 K090666 000
00841132113912 K090666 000
00841132113929 K090666 000
00841132113936 K090666 000
00841132113943 K090666 000
00841132113950 K090666 000
00841132113967 K090666 000
00841132113974 K090666 000
00841132123683 K090666 000

Trademark Results [PEDIPLATES]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDIPLATES
PEDIPLATES
86447652 4958205 Live/Registered
OrthoPediatrics Corp.
2014-11-07
PEDIPLATES
PEDIPLATES
77514366 3707114 Live/Registered
ORTHOPEDIATRICS CORP.
2008-07-03

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