X-STOP® Interspinous Spacer

GUDID 00613994598547

SPACER 1-3216 US 16MM X STOPPK

MEDTRONIC SOFAMOR DANEK, INC.

Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar interspinous decompression spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer Lumbar decompression interspinous spacer

• Primary Device ID: 00613994598547
• NIH Device Record Key: a846a011-5776-42af-bfc7-9edbd37acf6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-STOP® Interspinous Spacer
• Version Model Number: 1-3216
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994598547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040001

FDA Product Code

• NQO: Prosthesis, spinous process spacer/plate

Sterilization

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

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