ORTHOLOC® 3Di Small Bones Plating

Plate, Fixation, Bone

Wright Medical Technology, Inc.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc® 3di Small Bones Plating.

Pre-market Notification Details

Device IDK163039
510k NumberK163039
Device Name:ORTHOLOC® 3Di Small Bones Plating
ClassificationPlate, Fixation, Bone
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactMichael Mullins
CorrespondentMichael Mullins
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-31
Decision Date2017-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420185471 K163039 000
00840420185327 K163039 000
00840420185334 K163039 000
00840420185341 K163039 000
00840420185358 K163039 000
00840420185365 K163039 000
00840420185372 K163039 000
00840420185389 K163039 000
00840420185396 K163039 000
00840420185402 K163039 000
00840420185419 K163039 000
00840420185426 K163039 000
00840420185433 K163039 000
00840420185440 K163039 000
00840420185457 K163039 000
00840420185464 K163039 000
00840420185310 K163039 000

Trademark Results [ORTHOLOC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOLOC
ORTHOLOC
77636931 4222143 Live/Registered
Wright Medical Technology, Inc.
2008-12-19
ORTHOLOC
ORTHOLOC
73596966 1417357 Live/Registered
DOW CORNING CORPORATION
1986-05-05

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