SeaSpine Spacer System - Hollywood™ NanoMetalene® 34-5109

GUDID 10889981034665

Hollywood NM Implant, 11mm x 27mm x 9mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981034665
• NIH Device Record Key: 579b27d8-3ac1-452c-badb-608340cac13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Hollywood™ NanoMetalene®
• Version Model Number: 34-5109
• Catalog Number: 34-5109
• 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	10889981034665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102026

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981034665]

Moist Heat or Steam Sterilization

[10889981034665]

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 [SeaSpine Spacer System - Hollywood™ NanoMetalene®]

• 10889981049652: Hollywood NM Implant Caddy
• 10889981034719: Hollywood NM Implant, 11mm x 27mm x 14mm, Lordotic
• 10889981034702: Hollywood NM Implant, 11mm x 27mm x 13mm, Lordotic
• 10889981034696: Hollywood NM Implant, 11mm x 27mm x 12mm, Lordotic
• 10889981034689: Hollywood NM Implant, 11mm x 27mm x 11mm, Lordotic
• 10889981034672: Hollywood NM Implant, 11mm x 27mm x 10mm, Lordotic
• 10889981034665: Hollywood NM Implant, 11mm x 27mm x 9mm, Lordotic
• 10889981034658: Hollywood NM Implant, 11mm x 27mm x 8mm, Lordotic
• 10889981034641: Hollywood NM Implant, 11mm x 27mm x 7mm, Lordotic