| Primary Device ID | 00613994848208 |
| NIH Device Record Key | e573d703-7cca-4ed4-b01f-8593786f0b78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crescent Spinal System Titanium |
| Version Model Number | 6681130 |
| 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 |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | 00613994848208 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
[00613994848208]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-09-09 |
| 00613994907936 | TRIAL 9501630 16MMX30MM STR |
| 00613994907929 | TRIAL 9501530 15MMX30MM STR |
| 00613994907912 | TRIAL 9501430 14MMX30MM STR |
| 00613994907905 | TRIAL 9501330 13MMX30MM STR |
| 00613994907899 | TRIAL 9501230 12MMX30MM STR |
| 00613994907882 | TRIAL 9501130 11MMX30MM STR |
| 00613994907875 | TRIAL 9501030 10MMX30MM STR |
| 00613994907868 | TRIAL 9500930 09MMX30MM STR |
| 00613994907851 | TRIAL 9500830 08MMX30MM STR |
| 00613994907844 | TRIAL 9500730 07MMX30MM STR |
| 00613994907776 | TRIAL 9503016 16MMX30MM ANG |
| 00613994907769 | TRIAL 9503015 15MMX30MM ANG |
| 00613994907752 | TRIAL 9503014 14MMX30MM ANG |
| 00613994907745 | TRIAL 9503013 13MMX30MM ANG |
| 00613994907738 | TRIAL 9503012 12MMX30MM ANG |
| 00613994907721 | TRIAL 9503011 11MMX30MM ANG |
| 00613994907714 | TRIAL 9503010 10MMX30MM ANG |
| 00613994907707 | TRIAL 9503009 09MMX30MM ANG |
| 00613994907691 | TRIAL 9503008 08MMX30MM ANG |
| 00613994907684 | TRIAL 9503007 07MMX30MM ANG |
| 00613994898111 | INSERTER 6660004 SHAFT |
| 00613994880239 | SPACER X0310662 CRESCENT PK TAPERED 25X7 |
| 00613994880222 | SPACER X0310663 CRESCENT PK TAPERED 25X8 |
| 00613994880215 | SPACER X0310664 CRESCENT PK TAPERED 25X9 |
| 00613994880208 | SPACER X0310665 CRESCENT PK TAPERD 25X10 |
| 00613994880192 | SPACER X0310666 CRESCENT PK TAPERD 25X11 |
| 00613994880185 | SPACER X0310667 CRESCENT PK TAPERD 25X12 |
| 00613994880178 | SPACER X0310668 CRESCENT PK TAPERD 25X13 |
| 00613994880161 | SPACER X0310669 CRESCENT PK TAPERD 25X14 |
| 00613994880154 | SPACER X0310670 CRESCENT PK TAPERD 25X15 |
| 00613994880147 | SPACER X0610001 CRESCENT PK TAPERED 30X7 |
| 00613994880130 | SPACER X0610002 CRESCENT PK TAPERED 30X8 |
| 00613994880123 | SPACER X0610003 CRESCENT PK TAPERED 30X9 |
| 00613994880116 | SPACER X0610004 CRESCENT PK TAPERD 30X10 |
| 00613994880109 | SPACER X0610005 CRESCENT PK TAPERD 30X11 |
| 00613994880093 | SPACER X0610006 CRESCENT PK TAPERD 30X12 |
| 00613994880086 | SPACER X0610007 CRESCENT PK TAPERD 30X13 |
| 00613994880079 | SPACER X0610008 CRESCENT PK TAPERD 30X14 |
| 00613994880062 | SPACER X0610009 CRESCENT PK TAPERD 30X15 |
| 00613994849502 | SPACER 6670725 CRESCENT TI WD 07MMX25MM |
| 00613994849496 | SPACER 6670730 CRESCENT TI WD 07MMX30MM |
| 00613994849489 | SPACER 6670736 CRESCENT TI WD 07MMX36MM |
| 00613994849472 | SPACER 6670825 CRESCENT TI WD 08MMX25MM |
| 00613994849465 | SPACER 6670830 CRESCENT TI WD 08MMX30MM |
| 00613994849458 | SPACER 6670836 CRESCENT TI WD 08MMX36MM |
| 00613994849441 | SPACER 6670925 CRESCENT TI WD 09MMX25MM |
| 00613994849434 | SPACER 6670930 CRESCENT TI WD 09MMX30MM |
| 00613994849427 | SPACER 6670936 CRESCENT TI WD 09MMX36MM |
| 00613994849410 | SPACER 6671025 CRESCENT TI WD 10MMX25MM |
| 00613994849403 | SPACER 6671030 CRESCENT TI WD 10MMX30MM |