SeaSpine Spacer System - Hollywood™ 34-8014

GUDID 10889981034597

Hollywood VI Implant, 11mm x 27mm x 14mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981034597
• NIH Device Record Key: 5e4d2bd1-2ea5-4342-a2b1-db9b4cd75f82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Hollywood™
• Version Model Number: 34-8014
• Catalog Number: 34-8014
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981034597 [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

[10889981034597]

Moist Heat or Steam Sterilization

[10889981034597]

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™]

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• 10889981058418: 17mm Hollywood Trial, Lordotic
• 10889981058401: 16mm Hollywood Trial, Lordotic
• 10889981058395: 15mm Hollywood Trial, Lordotic
• 10889981058388: 14mm Hollywood Trial, Lordotic
• 10889981058371: 13mm Hollywood Trial, Lordotic
• 10889981058364: 12mm Hollywood Trial, Lordotic
• 10889981058357: 11mm Hollywood Trial, Lordotic
• 10889981058340: 10mm Hollywood Trial, Lordotic
• 10889981058333: 9mm Hollywood Trial, Lordotic
• 10889981058326: 8mm Hollywood Trial, Lordotic
• 10889981058319: 7mm Hollywood Trial, Lordotic
• 10889981058302: Hollywood Implant, 11mm x 27mm x 18mm, Lordotic
• 10889981058296: Hollywood Implant, 11mm x 27mm x 17mm, Lordotic
• 10889981058289: Hollywood Implant, 11mm x 27mm x 16mm, Lordotic
• 10889981058272: Hollywood Implant, 11mm x 27mm x 15mm, Lordotic
• 10889981058265: Hollywood Implant, 11mm x 27mm x 14mm, Lordotic
• 10889981058258: Hollywood Implant, 11mm x 27mm x 13mm, Lordotic
• 10889981058241: Hollywood Implant, 11mm x 27mm x 12mm, Lordotic
• 10889981058234: Hollywood Implant, 11mm x 27mm x 11mm, Lordotic
• 10889981058227: Hollywood Implant, 11mm x 27mm x 10mm, Lordotic
• 10889981058210: Hollywood Implant, 11mm x 27mm x 9mm, Lordotic
• 10889981058203: Hollywood Implant, 11mm x 27mm x 8mm, Lordotic
• 10889981058197: Hollywood Implant, 11mm x 27mm x 7mm, Lordotic
• 10889981034634: Hollywood VI Implant, 11mm x 27mm x 18mm, Lordotic
• 10889981034627: Hollywood VI Implant, 11mm x 27mm x 17mm, Lordotic
• 10889981034610: Hollywood VI Implant, 11mm x 27mm x 16mm, Lordotic
• 10889981034603: Hollywood VI Implant, 11mm x 27mm x 15mm, Lordotic
• 10889981034597: Hollywood VI Implant, 11mm x 27mm x 14mm, Lordotic
• 10889981034580: Hollywood VI Implant, 11mm x 27mm x 13mm, Lordotic
• 10889981034573: Hollywood VI Implant, 11mm x 27mm x 12mm, Lordotic
• 10889981034566: Hollywood VI Implant, 11mm x 27mm x 11mm, Lordotic
• 10889981034559: Hollywood VI Implant, 11mm x 27mm x 10mm, Lordotic
• 10889981034542: Hollywood VI Implant, 11mm x 27mm x 9mm, Lordotic
• 10889981034535: Hollywood VI Implant, 11mm x 27mm x 8mm, Lordotic
• 10889981034528: Hollywood VI Implant, 11mm x 27mm x 7mm, Lordotic
• 10889981031305: 18mm Hollywood Trial, Lordotic
• 10889981031299: 17mm Hollywood Trial, Lordotic
• 10889981031282: 16mm Hollywood Trial, Lordotic
• 10889981031275: 15mm Hollywood Trial, Lordotic
• 10889981031268: 14mm Hollywood Trial, Lordotic
• 10889981031251: 13mm Hollywood Trial, Lordotic
• 10889981031244: 12mm Hollywood Trial, Lordotic
• 10889981031237: 11mm Hollywood Trial, Lordotic
• 10889981031220: 10mm Hollywood Trial, Lordotic
• 10889981031213: 9mm Hollywood Trial, Lordotic
• 10889981031206: 8mm Hollywood Trial, Lordotic
• 10889981031190: 7mm Hollywood Trial, Lordotic
• 10889981031183: 18mm Hollywood Trial, Lordotic, Short
• 10889981031176: 17mm Hollywood Trial, Lordotic, Short