VuMesh™ 15-11-1425

GUDID 10889981036546

14mm Sq Spacer X 2.5mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981036546
• NIH Device Record Key: 6df787a6-b2ac-463b-8fb0-b1ee3a21a44e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VuMesh™
• Version Model Number: 15-11-1425
• Catalog Number: 15-11-1425
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981036546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070381

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981036546]

Moist Heat or Steam Sterilization

[10889981036546]

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: 2015-09-24

On-Brand Devices [VuMesh™]

• 10889981062484: VuMESH™ SET
• 10889981036713: 10mm Inserter
• 10889981036706: End Cap (10mm Cage) 14mm, 7.5 Deg
• 10889981036690: End Cap (10mm Cage) 14mm, 5.0 Deg
• 10889981036683: End Cap (10mm Cage) 14mm, 2.5 Deg
• 10889981036676: End Cap (10mm Cage) 14mm, 0 Deg
• 10889981036669: End Cap (10mm Cage) 12mm, 7.5 Deg
• 10889981036652: End Cap (10mm Cage) 12mm, 5.0 Deg
• 10889981036645: End Cap (10mm Cage) 12mm, 2.5 Deg
• 10889981036638: End Cap (10mm Cage) 12mm, 0 Deg
• 10889981036621: 14mm Sq 7.5 Deg End Cap
• 10889981036614: 14mm Sq 5 Deg End Cap
• 10889981036607: 14mm Sq 2.5 Deg End Cap
• 10889981036591: 14mm Sq Non-angled End Cap
• 10889981036584: 12mm Sq 7.5 Deg End Cap
• 10889981036577: 12mm Sq 5 Deg End Cap
• 10889981036560: 12mm Sq 2.5 Deg End Cap
• 10889981036553: 12mm Sq Non-angled End Cap
• 10889981036546: 14mm Sq Spacer X 2.5mm
• 10889981036539: 14mm Sq Spacer X 2.0mm
• 10889981036522: 14mm Sq Spacer X 1.5mm
• 10889981036515: 14mm Sq Spacer X 1.0mm
• 10889981036508: 12mm Sq Spacer X 2.5mm
• 10889981036492: 12mm Sq Spacer X 2.0mm
• 10889981036485: 12mm Sq Spacer X 1.5mm
• 10889981036478: 12mm Sq Spacer X 1.0mm
• 10889981036461: 14mm Sq Cage X 70mm Long
• 10889981036454: 14mm Sq Cage X 65mm Long
• 10889981036447: 14mm Sq Cage X 60mm Long
• 10889981036430: 14mm Sq Cage X 55mm Long
• 10889981036423: 14mm Sq Cage X 50mm Long
• 10889981036416: 14mm Sq Cage X 45mm Long
• 10889981036409: 14mm Sq Cage X 40mm Long
• 10889981036393: 14mm Sq Cage X 35mm Long
• 10889981036386: 14mm Sq Cage X 30mm Long
• 10889981036379: 14mm Sq Cage X 25mm Long
• 10889981036362: 14mm Sq Cage X 20mm Long
• 10889981036355: 14mm Sq Cage X 15mm Long
• 10889981036348: 14mm Sq Cage X 10mm Long
• 10889981036331: 12mm Sq Cage X 70mm Long
• 10889981036324: 12mm Sq Cage X 65mm Long
• 10889981036317: 12mm Sq Cage X 60mm Long
• 10889981036300: 12mm Sq Cage X 55mm Long
• 10889981036294: 12mm Sq Cage X 50mm Long
• 10889981036287: 12mm Sq Cage X 45mm Long
• 10889981036270: 12mm Sq Cage X 40mm Long
• 10889981036263: 12mm Sq Cage X 35mm Long
• 10889981036256: 12mm Sq Cage X 30mm Long
• 10889981036249: 12mm Sq Cage X 25mm Long
• 10889981036232: 12mm Sq Cage X 20mm Long