Spinous Process System 95-3002

GUDID 10889981096175

Ligament Splitter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implantable-device cutter

• Primary Device ID: 10889981096175
• NIH Device Record Key: d521b9a6-65f9-422a-9d6e-0c5b7778415f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinous Process System
• Version Model Number: 95-3002
• Catalog Number: 95-3002
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981096175 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10889981096175]

Moist Heat or Steam Sterilization

[10889981096175]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-21
• Device Publish Date: 2018-04-18

On-Brand Devices [Spinous Process System]

• 10889981129705: Plate Inserter, Spinous Process Spacer
• 10889981129613: Spinous Process Implants and Instruments
• 10889981120603: Spinous Process Tray, Caddy
• 10889981096281: 16mm Trial, Spinous Process Spacer
• 10889981096274: 14mm Trial, Spinous Process Spacer
• 10889981096267: 12mm Trial, Spinous Process Spacer
• 10889981096250: 10mm Trial, Spinous Process Spacer
• 10889981096243: 8mm Trial, Spinous Process Spacer
• 10889981096236: 6mm Trial, Spinous Process Spacer
• 10889981096205: Compressor, Spinous Process Spacer
• 10889981096199: Inserter, Spinous Process Spacer
• 10889981096175: Ligament Splitter
• 10889981096151: T15 Driver
• 10889981076238: Spinous Process Spacer, 16mm
• 10889981076221: Spinous Process Spacer, 14mm
• 10889981076214: Spinous Process Spacer, 12mm
• 10889981076207: Spinous Process Spacer, 10mm
• 10889981076191: Spinous Process Spacer, 8mm
• 10889981076184: Spinous Process Spacer, 6mm