X-STOP® Interspinous Spacer
GUDID 00643169132702
SPACER 1-2214 US 14MM X-STOP
MEDTRONIC SOFAMOR DANEK, INC.
Lumbar interspinous decompression spacer| Primary Device ID | 00643169132702 |
| NIH Device Record Key | 93e3fce7-f1c8-4b5e-8538-4d33853aba01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-STOP® Interspinous Spacer |
| Version Model Number | 1-2214 |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169132702 [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 |
Trademark Results [X-STOP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-STOP 76423051 2695629 Dead/Cancelled |
MEDTRONIC HOLDING COMPANY SARL 2002-06-20 |
 X-STOP 76048245 2447919 Dead/Cancelled |
LOGON DATA CORPORATION 2000-05-15 |
 X-STOP 75577522 2457911 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 1998-10-27 |
 X-STOP 75124165 not registered Dead/Abandoned |
LOGON DATA CORPORATION 1996-06-24 |
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