SeaSpine Spacer System - Hollywood NanoMetalene 34-8108

GUDID 10889981034771

Hollywood VI NM Implant, 11mm x 27mm x 8mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981034771
• NIH Device Record Key: 69cbd648-739a-4eb4-a815-ba36edb56f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Hollywood NanoMetalene
• Version Model Number: 34-8108
• Catalog Number: 34-8108
• 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: 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(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	10889981034771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102026

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981034771]

Moist Heat or Steam Sterilization

[10889981034771]

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: 2016-05-20

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