Facet 58-0458

GUDID 10889981122485

Facet Screw 4.5MM x 58MM

SEASPINE ORTHOPEDICS CORPORATION

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 10889981122485
• NIH Device Record Key: cbeb4d66-a0f4-41b3-8389-9e5047680488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet
• Version Model Number: 58-0458
• Catalog Number: 58-0458
• 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: 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	10889981122485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132859

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[10889981122485]

Moist Heat or Steam Sterilization

[10889981122485]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-04

On-Brand Devices [Facet]

• 10889981122485: Facet Screw 4.5MM x 58MM
• 10889981213183: Facet Prep Instrumentation Tray - Lid
• 10889981213176: Facet Prep Instrumentation Tray - Base, Cervical
• 10889981213169: Tamp, 5.0mm
• 10889981213152: Drill, 5.0mm
• 10889981213145: Inserter, Cervical