Spinous Process System 53-4208

GUDID 10889981076191

Spinous Process Spacer, 8mm

SEASPINE ORTHOPEDICS CORPORATION

Interspinous spinal fixation implant

• Primary Device ID: 10889981076191
• NIH Device Record Key: 211f327a-3e04-48e6-84f5-678158256e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinous Process System
• Version Model Number: 53-4208
• Catalog Number: 53-4208
• 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	10889981076191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121924

FDA Product Code

• PEK: Spinous process plate

Sterilization

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

[10889981076191]

Moist Heat or Steam Sterilization

[10889981076191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-12-17

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