X-STOP® Interspinous Spacer

GUDID 00643169117693

HANDLE 2-4000 X STOP HORIZONTAL US

MEDTRONIC SOFAMOR DANEK, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00643169117693
• NIH Device Record Key: cb0c3726-91d3-42f0-b270-bbf8a2f98f11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-STOP® Interspinous Spacer
• Version Model Number: 2-4000
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169117693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040001

FDA Product Code

• NQO: Prosthesis, spinous process spacer/plate

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

[00643169117693]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-23

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

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