Facet Fixation 58-0446

GUDID 10889981076610

Facet Screw 4.5MM x 46MM

SEASPINE ORTHOPEDICS CORPORATION

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 10889981076610
• NIH Device Record Key: d98c3dda-05fd-480a-aabd-a2ec70a043f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet Fixation
• Version Model Number: 58-0446
• Catalog Number: 58-0446
• 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	10889981076610 [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

[10889981076610]

Moist Heat or Steam Sterilization

[10889981076610]

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 Fixation]

• 10889981143183: Facet Lag Screw, 4.5mm x 54mm
• 10889981143176: Facet Screw, 4.5mm x 54mm
• 10889981122836: Facet Lag Screw 4.5MM x 58MM
• 10889981100674: Washer Caddy
• 10889981100667: 4.5mm Lag Screw Caddy
• 10889981100650: 4.5mm Screw Caddy
• 10889981100643: Facet Tray Lid
• 10889981100636: Facet Tray Insert
• 10889981100629: Facet Tray Base
• 10889981100612: Facet Tray
• 10889981100605: Dilator Handle
• 10889981100599: Retrieval Tool
• 10889981100582: Large Dilator
• 10889981100575: Medium Dilator
• 10889981100568: Small Dilator
• 10889981100551: Drill Guide
• 10889981100544: 5.0mm Cannulated Tap
• 10889981100537: 4.5mm Cannulated Tap
• 10889981100520: Access Needle Stylet
• 10889981100513: Slim T Handle
• 10889981100506: Ratcheting Pineapple Handle Push Forward
• 10889981100490: Facet Access Needle
• 10889981100483: Facet Universal Driver Shaft
• 10889981100476: Facet Universal Driver Handle
• 10889981100469: Washer Retaining Sheath
• 10889981100452: Drill for DIA 5.0mm Facet Screw
• 10889981100445: Drill for DIA 4.5mm Facet Screw
• 10889981100438: 3.5mm Cannulated Driver
• 10889981100421: Guidewire, 25 in
• 10889981077037: Facet Lag Screw 4.5MM x 55MM
• 10889981077020: Facet Lag Screw 4.5MM x 50MM
• 10889981077006: Facet Lag Screw 4.5MM x 46MM
• 10889981076979: Facet Lag Screw 4.5MM x 42MM
• 10889981076955: Facet Lag Screw 4.5MM x 38MM
• 10889981076931: Facet Lag Screw 4.5MM x 34MM
• 10889981076917: Facet Lag Screw 4.5MM x 30MM
• 10889981076894: Facet Lag Screw 4.5MM x 26MM
• 10889981076641: Facet Screw 4.5MM x 55MM
• 10889981076634: Facet Screw 4.5MM x 50MM
• 10889981076610: Facet Screw 4.5MM x 46MM
• 10889981076597: Facet Screw 4.5MM x 42MM
• 10889981076573: Facet Screw 4.5MM x 38MM
• 10889981076559: Facet Screw 4.5MM x 34MM
• 10889981076535: Facet Screw 4.5MM x 30MM
• 10889981076511: Facet Screw 4.5MM x 26MM
• 10889981076467: Facet Washer