Tritium® Sternal Cable Plate System

Cerclage, Fixation

Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. Dba Rti Surgical, Inc. with the FDA for Tritium® Sternal Cable Plate System.

Pre-market Notification Details

Device IDK161876
510k NumberK161876
Device Name:Tritium® Sternal Cable Plate System
ClassificationCerclage, Fixation
Applicant Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 375 River Park Circle Marquette,  MI  49855
ContactSarah Pleaugh
CorrespondentSarah Pleaugh
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 375 River Park Circle Marquette,  MI  49855
Product CodeJDQ  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-08
Decision Date2016-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846468078164 K161876 000
00846468078157 K161876 000
00846468078140 K161876 000

Trademark Results [Tritium]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRITIUM
TRITIUM
97720096 not registered Live/Pending
WTNZ AGENCY, INC.
2022-12-15
TRITIUM
TRITIUM
97683922 not registered Live/Pending
Episode Six Inc.
2022-11-18
TRITIUM
TRITIUM
87713324 5528914 Live/Registered
Tritium Holdings Pty Ltd
2017-12-08
TRITIUM
TRITIUM
86963288 5077710 Live/Registered
Episode Six Limited
2016-04-04
TRITIUM
TRITIUM
85647984 4279513 Dead/Cancelled
Meyer, Brett T
2012-06-10
TRITIUM
TRITIUM
85505687 4488946 Live/Registered
A&E ADVANCED CLOSURE SYSTEMS, LLC
2011-12-29
TRITIUM
TRITIUM
85034692 not registered Dead/Abandoned
Allen, David M.
2010-05-10
TRITIUM
TRITIUM
79271269 not registered Live/Pending
Finnluxury Oy
2019-09-19
TRITIUM
TRITIUM
78507656 not registered Dead/Abandoned
SLODOWITZ, MOTTI, M
2004-10-28
TRITIUM
TRITIUM
77127537 3655201 Dead/Cancelled
TriQuint Semiconductor, Inc.
2007-03-09
TRITIUM
TRITIUM
76641105 not registered Dead/Abandoned
Allen, David
2005-06-17
TRITIUM
TRITIUM
75636561 2361752 Dead/Cancelled
Tritium Network, Inc.
1999-02-08

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