VERTE-STACK® Spinal System
GUDID 00613994220219
SPACER X030651808 VS PK VBS END10X18X8
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994220219 |
| NIH Device Record Key | 8100c2dd-0327-40cd-a1cc-3b8d18e24690 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERTE-STACK® Spinal System |
| Version Model Number | X030651808 |
| 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 |
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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994220219 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041556
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
[00613994220219]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-20 |
On-Brand Devices [VERTE-STACK® Spinal System]
| 00613994733733 | TRIAL X0909793 18X12 |
| 00613994729071 | CAP X0909779 CS PSR PK ANA 5X18X12 |
| 00613994729064 | CAP X0909780 CS PSR PK ANA 6X18X12 |
| 00613994729057 | CAP X0909781 CS PSR PK ANA 7X18X12 |
| 00613994729040 | CAP X0909782 CS PSR PK ANA 8X18X12 |
| 00613994729033 | CAP X0909783 CS PSR PK ANA 9X18X12 |
| 00613994729026 | CAP X0909784 CS PSR PK ANA 10X18X12 |
| 00613994729019 | STRUT X0909785 ANATOMIC PEEK 5X18X12 |
| 00613994729002 | CAP X0909786 ANATOMIC PEEK 5X20X12 |
| 00613994728999 | CAP X0909787 CS PSR PK ANA 12X20X6 |
| 00613994728982 | CAP X0909788 CS PSR PK ANA 12X20X7 |
| 00613994728975 | CAP X0909789 CS PSR PK ANA 12X20X8 |
| 00613994728968 | CAP X0909790 CS PSR PK ANA 12X20X9 |
| 00613994728951 | CAP X0909791 CS PSR PK ANA 12X20X10 |
| 00613994728944 | STRUT X0909792 ANATOMIC PEEK 5X20X12 |
| 00613994714442 | STRUT X1109041 CENTER PK 13X26 |
| 00613994714435 | STRUT X1109040 CENTER PK 11X26 |
| 00613994714428 | STRUT X1109039 CENTER PK 9X26 |
| 00613994714411 | STRUT X1109038 CENTER PK 14X22 |
| 00613994714404 | STRUT X1109037 CENTER PK 13X22 |
| 00613994714398 | STRUT X1109036 CENTER PK 12X22 |
| 00613994714381 | STRUT X1109035 CENTER PK 11X22 |
| 00613994714374 | STRUT X1109034 CENTER PK 10X22 |
| 00613994714367 | STRUT X1109033 CENTER PK 9X22 |
| 00613994714350 | STRUT X1109032 CENTER PK 8X22 |
| 00613994712721 | STRUT X1109002 TI CRESCENT 30X40 |
| 00613994692320 | STRUT X1009227 MED CNTR TI 0DEG 22MM |
| 00613994692313 | STRUT X1009228 MED CNTR TI 0DEG 26MM |
| 00613994692306 | STRUT X1009229 MED CNTR TI 0DEG 30MM |
| 00613994692290 | STRUT X1009230 MED CNTR TI 0DEG 38MM |
| 00613994692283 | STRUT X1009231 MED CNTR TI 0DEG 42MM |
| 00613994692276 | STRUT X1009232 MED CNTR TI 0DEG 46MM |
| 00613994692269 | STRUT X1009233 MED CNTR TI 0DEG 60MM |
| 00613994692252 | STRUT X1009234 LRG CNTR TI 0DEG 22MM |
| 00613994692245 | STRUT X1009235 LRG CNTR TI 0DEG 26MM |
| 00613994692238 | STRUT X1009236 LRG CNTR TI 0DEG 30MM |
| 00613994692221 | STRUT X1009237 LRG CNTR TI 0DEG 38MM |
| 00613994692214 | STRUT X1009238 LRG CNTR TI 0DEG 42MM |
| 00613994692207 | STRUT X1009239 LRG CNTR TI 0DEG 46MM |
| 00613994692191 | STRUT X1009240 LRG CNTR TI 0DEG 60MM |
| 00613994675538 | STRUT X0709161 8X22X3 DEG CENTER |
| 00613994675521 | STRUT X0709162 10X22X3 DEG CENTER |
| 00613994675514 | STRUT X0709163 12X22X3 DEG CENTER |
| 00613994675507 | STRUT X0709164 8X22X6 DEG CENTER |
| 00613994675491 | STRUT X0709165 10X22X6 DEG CENTER |
| 00613994675484 | STRUT X0709166 12X22X6 DEG CENTER |
| 00613994675477 | STRUT X0709167 8X22X9 DEG CENTER |
| 00613994675460 | STRUT X0709168 10X22X9 DEG CENTER |
| 00613994675453 | STRUT X0709169 12X22X9 DEG CENTER |
| 00613994675446 | STRUT X0709170 8X26X3 DEG CENTER |
Trademark Results [VERTE-STACK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTE-STACK 78100037 2774125 Dead/Cancelled |
MEDTRONIC SOFAMOR DANEK INC. 2001-12-27 |
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