| Primary Device ID | 00613994147585 |
| NIH Device Record Key | c02bab24-5b03-4b1c-bed6-df8fb20a44bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERTESTACK® Spinal System |
| Version Model Number | X1205299 |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994147585 [Primary] |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994147585]
Moist Heat or Steam Sterilization
[00613994147585]
Moist Heat or Steam Sterilization
[00613994147585]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-08-18 |
| 00613994156402 | SPACER 636953 PERIMETER XS 9X15X13MM |
| 00613994156396 | SPACER 636932 PERIMETER XS 9X13X12MM |
| 00613994156389 | SPACER 636853 PERIMETER XS 8X15X13MM |
| 00613994156372 | SPACER 636832 PERIMETER XS 8X13X12MM |
| 00613994156365 | SPACER 636753 PERIMETER XS 7X15X13MM |
| 00613994156341 | SPACER 636732 PERIMETER XS 7X13X12MM |
| 00613994156334 | SPACER 636653 PERIMETER XS 6X15X13MM |
| 00613994156327 | SPACER 636632 PERIMETER XS 6X13X12MM |
| 00613994156310 | SPACER 636553 PERIMETER XS 5X15X13MM |
| 00613994156297 | SPACER 636532 PERIMETER XS 5X13X12MM |
| 00613994156266 | SPACER 636253 PERIMETER XS 12X15X13MM |
| 00613994156259 | SPACER 636232 PERIMETER XS 12X13X12MM |
| 00613994156242 | SPACER 636153 PERIMETER XS 11X15X13MM |
| 00613994156228 | SPACER 636132 PERIMETER XS 11X13X12MM |
| 00613994156211 | SPACER 636053 PERIMETER XS 10X15X13MM |
| 00613994156204 | SPACER 636032 PERIMETER XS 10X13X12MM |
| 00613994151018 | SPACER X0905257 CAPSTONE VS PEK VBS END |
| 00613994150998 | SPACER X0905255 CAPSTONE VS PEK VBS END |
| 00613994150974 | SPACER X0905253 CAPSTONE VS PEK VBS END |
| 00613994150936 | SPACER X0905249 CAPSTONE VS PEK VBS END |
| 00613994150899 | SPACER X0905245 CAPSTONE VS PEK VBS END |
| 00613994147653 | SPACER X1205306 TITANIUM IMP 15MM X 30MM |
| 00613994147646 | SPACER X1205305 TITANIUM IMP 14MM X 30MM |
| 00613994147639 | SPACER X1205304 TITANIUM IMP 13MM X 30MM |
| 00613994147622 | SPACER X1205303 TITANIUM IMP 12MM X 30MM |
| 00613994147615 | SPACER X1205302 TITANIUM IMP 11MM X 30MM |
| 00613994147608 | SPACER X1205301 TITANIUM IMP 10MM X 30MM |
| 00613994147592 | SPACER X1205300 TITANIUM IMP 9MM X 30MM |
| 00613994147585 | SPACER X1205299 TITANIUM IMP 8 MM X 30MM |
| 00613994147578 | SPACER X1205298 TITANIUM IMP 7MM X 30MM |
| 00613994119155 | SPACER 9193615 CRESCENT PEEK 36 X 15 |
| 00885074308647 | TELAMON P 8? 16 X 22 IMPLANT |
| 00885074242132 | SPACER 3393420 PRMTR LG ADD ON 12DG 20MM |
| 00885074242125 | SPACER 3393418 PRMTR LG ADD ON 12DG 18MM |
| 00885074242101 | SPACER 3393416 PRMTR LG ADD ON 12DG 16MM |
| 00885074242088 | SPACER 3393414 PRMTR LG ADD ON 12DG 14MM |
| 00885074242071 | SPACER 3393412 PRMTR LG ADD ON 12DG 12MM |
| 00885074242064 | SPACER 3393320 PRMTR LG ADD ON 8DG 20MM |
| 00885074242057 | SPACER 3393318 PRMTR LG ADD ON 8DG 18MM |
| 00885074242040 | SPACER 3393316 PRMTR LG ADD ON 8DG 16MM |
| 00885074242026 | SPACER 3393314 PRMTR LG ADD ON 8DG 14MM |