SeaSpine Spacer System - Hollywood VI NanoMetalene 34-8114-S

GUDID 00889981034835

Hollywood VI NM Sterile 11mm x 27mm x 14mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 00889981034835
• NIH Device Record Key: 0f5de837-8d43-44a9-87f6-4ad7d6299c0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Hollywood VI NanoMetalene
• Version Model Number: 34-8114-S
• Catalog Number: 34-8114-S
• 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: true
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889981034835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162715

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2016-11-02

On-Brand Devices [SeaSpine Spacer System - Hollywood VI NanoMetalene]

• 00889981120095: Hollywood VI NM Sterile 11mm x 30mm x 18mm, Lordotic
• 00889981064672: Hollywood VI NM Sterile 11mm x 30mm x 17mm, Lordotic
• 00889981064665: Hollywood VI NM Sterile 11mm x 30mm x 16mm, Lordotic
• 00889981064658: Hollywood VI NM Sterile 11mm x 30mm x 15mm, Lordotic
• 00889981064641: Hollywood VI NM Sterile 11mm x 30mm x 14mm, Lordotic
• 00889981064634: Hollywood VI NM Sterile 11mm x 30mm x 13mm, Lordotic
• 00889981064627: Hollywood VI NM Sterile 11mm x 30mm x 12mm, Lordotic
• 00889981064610: Hollywood VI NM Sterile 11mm x 30mm x 11mm, Lordotic
• 00889981064603: Hollywood VI NM Sterile 11mm x 30mm x 10mm, Lordotic
• 00889981064597: Hollywood VI NM Sterile 11mm x 30mm x 9mm, Lordotic
• 00889981064580: Hollywood VI NM Sterile 11mm x 30mm x 8mm, Lordotic
• 00889981034873: Hollywood VI NM Sterile 11mm x 27mm x 18mm, Lordotic
• 00889981034866: Hollywood VI NM Sterile 11mm x 27mm x 17mm, Lordotic
• 00889981034859: Hollywood VI NM Sterile 11mm x 27mm x 16mm, Lordotic
• 00889981034842: Hollywood VI NM Sterile 11mm x 27mm x 15mm, Lordotic
• 00889981034835: Hollywood VI NM Sterile 11mm x 27mm x 14mm, Lordotic
• 00889981034828: Hollywood VI NM Sterile 11mm x 27mm x 13mm, Lordotic
• 00889981034811: Hollywood VI NM Sterile 11mm x 27mm x 12mm, Lordotic
• 00889981034804: Hollywood VI NM Sterile 11mm x 27mm x 11mm, Lordotic
• 00889981034798: Hollywood VI NM Sterile 11mm x 27mm x 10mm, Lordotic
• 00889981034781: Hollywood VI NM Sterile 11mm x 27mm x 9mm, Lordotic
• 00889981034774: Hollywood VI NM Sterile 11mm x 27mm x 8mm, Lordotic
• 00889981034767: Hollywood VI NM Sterile 11mm x 27mm x 7mm, Lordotic