SeaSpine Spacer System - Hollywood NanoMetalene 34-5115-S

GUDID 00889981034729

Hollywood NM Sterile Implant, 11mm x 27mm x 15mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 00889981034729
• NIH Device Record Key: 5b964d77-37ad-4c99-813d-89d2c2f74e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Hollywood NanoMetalene
• Version Model Number: 34-5115-S
• Catalog Number: 34-5115-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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889981034729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162715

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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 NanoMetalene]

• 10889981129644: Hollywood VI NM Implant Caddy, 30mm
• 10889981129637: Hollywood VI NM Implant Caddy, 27mm
• 10889981064662: Hollywood VI NM Implant, 11mm x 30mm x 16mm, Lordotic
• 10889981064655: Hollywood VI NM Implant, 11mm x 30mm x 15mm, Lordotic
• 10889981064648: Hollywood VI NM Implant, 11mm x 30mm x 14mm, Lordotic
• 10889981064631: Hollywood VI NM Implant, 11mm x 30mm x 13mm, Lordotic
• 10889981064624: Hollywood VI NM Implant, 11mm x 30mm x 12mm, Lordotic
• 10889981064617: Hollywood VI NM Implant, 11mm x 30mm x 11mm, Lordotic
• 10889981064600: Hollywood VI NM Implant, 11mm x 30mm x 10mm, Lordotic
• 10889981064594: Hollywood VI NM Implant, 11mm x 30mm x 9mm, Lordotic
• 10889981064587: Hollywood VI NM Implant, 11mm x 30mm x 8mm, Lordotic
• 10889981034856: Hollywood VI NM Implant, 11mm x 27mm x 16mm, Lordotic
• 10889981034849: Hollywood VI NM Implant, 11mm x 27mm x 15mm, Lordotic
• 10889981034832: Hollywood VI NM Implant, 11mm x 27mm x 14mm, Lordotic
• 10889981034825: Hollywood VI NM Implant, 11mm x 27mm x 13mm, Lordotic
• 10889981034818: Hollywood VI NM Implant, 11mm x 27mm x 12mm, Lordotic
• 10889981034801: Hollywood VI NM Implant, 11mm x 27mm x 11mm, Lordotic
• 10889981034795: Hollywood VI NM Implant, 11mm x 27mm x 10mm, Lordotic
• 10889981034788: Hollywood VI NM Implant, 11mm x 27mm x 9mm, Lordotic
• 10889981034771: Hollywood VI NM Implant, 11mm x 27mm x 8mm, Lordotic
• 00889981034750: Hollywood NM Sterile Implant, 11mm x 27mm x 18mm, Lordotic
• 00889981034743: Hollywood NM Sterile Implant, 11mm x 27mm x 17mm, Lordotic
• 00889981034736: Hollywood NM Sterile Implant, 11mm x 27mm x 16mm, Lordotic
• 00889981034729: Hollywood NM Sterile Implant, 11mm x 27mm x 15mm, Lordotic
• 00889981034712: Hollywood NM Sterile Implant, 11mm x 27mm x 14mm, Lordotic
• 00889981034705: Hollywood NM Sterile Implant, 11mm x 27mm x 13mm, Lordotic
• 00889981034699: Hollywood NM Sterile Implant, 11mm x 27mm x 12mm, Lordotic
• 00889981034682: Hollywood NM Sterile Implant, 11mm x 27mm x 11mm, Lordotic
• 00889981034675: Hollywood NM Sterile Implant, 11mm x 27mm x 10mm, Lordotic
• 00889981034668: Hollywood NM Sterile Implant, 11mm x 27mm x 9mm, Lordotic
• 00889981034651: Hollywood NM Sterile Implant, 11mm x 27mm x 8mm, Lordotic
• 00889981034644: Hollywood NM Sterile Implant, 11mm x 27mm x 7mm, Lordotic