VICEROY Spinal System

GUDID 88000163011378

EOS BIOTEK,INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 88000163011378
• NIH Device Record Key: d36dd4a3-4f2c-419a-88f5-57e9d051a2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VICEROY Spinal System
• Version Model Number: V-0401 080
• Company DUNS: 689605712
• Company Name: EOS BIOTEK,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: true
• 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: +1-858-345-5840
• Email: Brandon@torreyspineusa.com
• Phone: +1-858-345-5840
• Email: Brandon@torreyspineusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	88000163011378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122229

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[88000163011378]

Moist Heat or Steam Sterilization

[88000163011378]

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: 2016-10-04

On-Brand Devices [VICEROY Spinal System]

• 88000163012504: V-0202 100
• 88000163012436: V-0202 095
• 88000163012368: V-0202 085
• 88000163012290: V-0202 075
• 88000163012122: V-0202 065
• 88000163012054: V-0202 055
• 88000163011996: V-0202 045
• 88000163011828: V-0201 120
• 88000163011750: V-0201 200
• 88000163011682: V-0401 110
• 88000163011514: V-0401 100
• 88000163011446: V-0401 090
• 88000163011378: V-0401 080
• 88000163011200: V-0401 075
• 88000163011132: V-0401 070
• 88000163011064: V-0204 LG
• 88000163010906: V-0204 MD
• 88000163010838: V-0204 SM
• 88000163010456: V-0401 065
• 88000163010388: V-0401 060
• 88000163010210: V-0401 055
• 88000163010142: V-0401 050
• 88000163010074: V-0401 045
• 88000163009948: V-0401 040
• 88000163009870: V-0401 035
• 88000163009702: V-0202 110
• 88000163009634: V-0202 090
• 88000163009566: V-0202 080
• 88000163009498: V-0202 070
• 88000163009320: V-0202 060
• 88000163009252: V-0202 050
• 88000163009184: V-0202 040
• 88000163009016: V-0202 035
• 88000163008958: V-0201 150
• 88000163007272: V-0101
• 88000163006978: V-0400 7550
• 88000163006800: V-0400 7545
• 88000163006732: V-0400 7540
• 88000163006664: V-0400 7535
• 88000163006350: V-0400 6550
• 88000163006282: V-0400 6545
• 88000163006114: V-0400 6540
• 88000163006046: V-0400 6535
• 88000163005742: V-0400 5550
• 88000163005674: V-0400 5545
• 88000163005506: V-0400 5540
• 88000163005438: V-0400 5535
• 88000163003458: V-0200 7555
• 88000163003380: V-0200 7550
• 88000163003212: V-0200 7545