SILC® Fixation System

Bone Fixation Cerclage, Sublaminar

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Silc® Fixation System.

Pre-market Notification Details

Device IDK172417
510k NumberK172417
Device Name:SILC® Fixation System
ClassificationBone Fixation Cerclage, Sublaminar
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactLori Burns
CorrespondentLori Burns
Globus Medical Inc. 2560 General Armistead Avenue Audubon,  PA  19403
Product CodeOWI  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-10
Decision Date2017-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889095493252 K172417 000
00889095493191 K172417 000
00193982146160 K172417 000
00193982146153 K172417 000

Trademark Results [SILC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILC
SILC
97419659 not registered Live/Pending
Jordan Wood
2022-05-19
SILC
SILC
97419659 not registered Live/Pending
Gary Weinstein
2022-05-19
SILC
SILC
87625291 5583986 Live/Registered
Secure Identity Ledger Corporation
2017-09-27
SILC
SILC
87374238 5472822 Live/Registered
The Universal Church, Inc.
2017-03-16
SILC
SILC
86080503 4685587 Live/Registered
Globus Medical, Inc
2013-10-02
SILC
SILC
85011439 3936965 Live/Registered
The Universal Church, Inc.
2010-04-12
SILC
SILC
77466010 3571796 Live/Registered
The Universal Church
2008-05-05
SILC
SILC
77250615 not registered Dead/Abandoned
aQuantive, Inc.
2007-08-08
SILC
SILC
77250611 not registered Dead/Abandoned
aQuantive, Inc.
2007-08-08
SILC
SILC
76558240 2895006 Live/Registered
SunTrust Banks, Inc.
2003-10-24
SILC
SILC
75322302 2460645 Dead/Cancelled
BDW Technology Pty Limited
1997-07-10
SILC
SILC
73756040 1734423 Dead/Cancelled
SHL SYSTEMHOUSE, INC.
1988-10-05

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