X-STOP® Interspinous Spacer

GUDID 00643169132702

SPACER 1-2214 US 14MM X-STOP

MEDTRONIC SOFAMOR DANEK, INC.

Lumbar interspinous decompression spacer
Primary Device ID00643169132702
NIH Device Record Key93e3fce7-f1c8-4b5e-8538-4d33853aba01
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-STOP® Interspinous Spacer
Version Model Number1-2214
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100643169132702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, spinous process spacer/plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-23

On-Brand Devices [X-STOP® Interspinous Spacer]

00613994598745SPACER 1-3212 US 12MM X STOPPK
00613994598738SPACER 1-3210 US 10MM X STOPPK
00613994598721SPACER 1-3208 US 8MM X STOPPK
00613994598714SPACER 1-3206 US 6MM X STOPPK
00613994598707SPACER 1-2214 US 14MM X STOP
00613994598691SPACER 1-2212 US 12MM X STOP
00613994598684SPACER 1-2210 US 10MM X STOP
00613994598677SPACER 1-2208 US 8MM X STOP
00613994598660SPACER 1-2206 US 6MM X STOP
00613994598653SPACER 1-3214 US 14MM X STOPPK
00613994598592DILATOR 2-2005 LARGE CURVED X STOP US
00613994598585DILATOR 2-2004 SMALL CURVED X STOP US
00613994598578DRIVER 2-2003 HEX TORQUE LIM X STOP US
00613994598561INSERTER 2-2002 UNI WING X STOP INST US
00613994598547SPACER 1-3216 US 16MM X STOPPK
00613994580139SPACER 2-4016 X STOP 16MM TRIAL US
00613994580115SPACER 2-4014 X STOP 14MM TRIAL US
00613994580092SPACER 2-4012 X STOP 12MM TRIAL US
00613994580078SPACER 2-4010 X STOP 10MM TRIAL US
00613994580054SPACER 2-4008 X STOP 8MM TRIAL US
00613994580030INSERTER 2-4001 X STOP SPACER TI US
00613994580016HANDLE 2-4000 X STOP HORIZONTAL US
00613994579980INSTRUMENTS 4-5500 X STOP PEEK US
00613994579904Sterilization Tray 3-4001 2 Tier US
00613994579898INSERTER 2-4301 X STOP SPACER PEEK US
00613994579850DISTRACTOR 2-4116 SIZING US
00613994455499INSERTER 2-2001 MAINBODY X STOP INST US
00613994455482INSERTER 2-2002 UNI WING X STOP INST US
00613994455475DRIVER 2-2003 HEX TORQUE LIM X STOP US
00613994455468DILATOR 2-2004 SMALL CURVED X STOP US
00613994455451DILATOR 2-2005 LARGE CURVED X STOP US
00613994455444DISTRACTOR 2-2016 XSTOP SIZING INST US
00613994455437INSERTER 2-2301 XSTOP PK SPCR INSERT US
00643169132856SPACER 1-3206 US 6MM X-STOP PEEK
00643169132849SPACER 1-3208 US 8MM X-STOP PEEK
00643169132832SPACER 1-3210 US 10MM X-STOP PEEK
00643169132825SPACER 1-3212 US 12MM X-STOP PEEK
00643169132818SPACER 1-3214 US 14MM X-STOP PEEK
00643169132801SPACER 1-3216 US 16MM X-STOP PEEK
00643169132740SPACER 1-2206 US 6MM X-STOP
00643169132733SPACER 1-2208 US 8MM X-STOP
00643169132726SPACER 1-2210 US 10MM X-STOP
00643169132719SPACER 1-2212 US 12MM X-STOP
00643169132702SPACER 1-2214 US 14MM X-STOP
00643169117761INSERTER 2-2001 MAINBODY X STOP INST US
00643169117754INSERTER 2-2002 UNI WING X STOP INST US
00643169117747DRIVER 2-2003 HEX TRORQUE LIM X STOP US
00643169117730DILATOR 2-2004 SMALL CURVED X STOP US
00643169117723DILATOR 2-2005 LARGE CURVED X STOP US
00643169117716DISTRACTOR 2-2016 X STOP SIZING INST US

Trademark Results [X-STOP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-STOP
X-STOP
76423051 2695629 Dead/Cancelled
MEDTRONIC HOLDING COMPANY SARL
2002-06-20
X-STOP
X-STOP
76048245 2447919 Dead/Cancelled
LOGON DATA CORPORATION
2000-05-15
X-STOP
X-STOP
75577522 2457911 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
1998-10-27
X-STOP
X-STOP
75124165 not registered Dead/Abandoned
LOGON DATA CORPORATION
1996-06-24

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