VERTE-STACK® Spinal System

GUDID 00885074520650

SPACER 9192515 CRESCENT PEEK 25X15

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis

• Primary Device ID: 00885074520650
• NIH Device Record Key: ecf2abea-cfe1-4da3-9da9-0f0dc3a40245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTE-STACK® Spinal System
• Version Model Number: 9192515
• 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

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074520650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052261

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-06-12

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