FacetFuse®

GUDID 00190361018209

Facet Screw, Gen 2, 16mm Fixed, 6.0x50mm

SPINEFRONTIER, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00190361018209
• NIH Device Record Key: fdf9d0ec-2291-4819-bad4-e9f3a3751907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FacetFuse®
• Version Model Number: 01-00014-6050
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, INC.
• Device Count: 1
• DM Exempt: true
• 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(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Length: 50 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361018209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071420

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

Moist Heat or Steam Sterilization

[00190361018209]

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: 2016-04-15

On-Brand Devices [FacetFuse®]

• 00190361020950: FacetFuse Screw, Small Washer Assy, 6.0 x 50mm
• 00190361020943: FacetFuse Screw, Small Washer Assy, 6.0 x 45mm
• 00190361020936: FacetFuse Screw, Small Washer Assy, 6.0 x 40mm
• 00190361020929: FacetFuse Screw, Small Washer Assy, 6.0 x 35mm
• 00190361020912: FacetFuse Screw, Small Washer Assy, 6.0 x 30mm
• 00190361020905: FacetFuse Screw, Small Washer Assy, 6.0 x 25mm
• 00190361020899: SMALL WASHER, FACET SCREW, ALLSIZES
• 00190361020882: FacetFuse Screw, Small Washer Assy, 5.5 x 50mm
• 00190361020875: FacetFuse Screw, Small Washer Assy, 5.5 x 45mm
• 00190361020868: FacetFuse Screw, Small Washer Assy, 5.5 x 40mm
• 00190361020851: FacetFuse Screw, Small Washer Assy, 5.5 x 35mm
• 00190361020844: FacetFuse Screw, Small Washer Assy, 5.5 x 30mm
• 00190361020837: FacetFuse Screw, Small Washer Assy, 5.5 x 25mm
• 00190361020820: FacetFuse Screw, Small Washer Assy, 5.0 x 50mm
• 00190361020813: FacetFuse Screw, Small Washer Assy, 5.0 x 45mm
• 00190361020806: FacetFuse Screw, Small Washer Assy, 5.0 x 40mm
• 00190361020790: FacetFuse Screw, Small Washer Assy, 5.0 x 35mm
• 00190361020783: FacetFuse Screw, Small Washer Assy, 5.0 x 30mm
• 00190361020776: FacetFuse Screw, Small Washer Assy, 5.0 x 25mm
• 00190361020769: FacetFuse Screw, Small Washer Assy, 4.5 x 50mm
• 00190361020752: FacetFuse Screw, Small Washer Assy, 4.5 x 45mm
• 00190361020745: FacetFuse Screw, Small Washer Assy, 4.5 x 40mm
• 00190361020738: FacetFuse Screw, Small Washer Assy, 4.5 x 35mm
• 00190361020721: FacetFuse Screw, Small Washer Assy, 4.5 x 30mm
• 00190361020714: FacetFuse Screw, Small Washer Assy, 4.5 x 25mm
• 00190361020707: FacetFuse Screw Assy, 5.0 x 25mm
• 00190361020691: FacetFuse Screw, 5.0 x 25mm (Washerless)
• 00190361020684: FacetFuse Screw Assy, 4.5 x 25mm
• 00190361020677: FacetFuse Screw, 4.5 x 25mm (Washerless)
• 00190361020660: FacetFuse Screw Assy, 6.0 x 50mm
• 00190361020653: FacetFuse Screw Assy, 6.0 x 45mm
• 00190361020646: FacetFuse Screw Assy, 6.0 x 40mm
• 00190361020639: FacetFuse Screw Assy, 6.0 x 35mm
• 00190361020622: FacetFuse Screw Assy, 6.0 x 30mm
• 00190361020615: FacetFuse Screw Assy, 6.0 x 25mm
• 00190361020608: FacetFuse Screw Assy, 5.5 x 50mm
• 00190361020592: FacetFuse Screw Assy, 5.5 x 45mm
• 00190361020585: FacetFuse Screw Assy, 5.5 x 40mm
• 00190361020578: FacetFuse Screw Assy, 5.5 x 35mm
• 00190361020561: FacetFuse Screw Assy, 5.5 x 30mm
• 00190361020554: FacetFuse Screw Assy, 5.5 x 25mm
• 00190361020547: FacetFuse Screw, 6.0 x 50mm (Washerless)
• 00190361020530: FacetFuse Screw, 6.0 x 45mm (Washerless)
• 00190361020523: FacetFuse Screw, 6.0 x 40mm (Washerless)
• 00190361020516: FacetFuse Screw, 6.0 x 35mm (Washerless)
• 00190361020509: FacetFuse Screw, 6.0 x 30mm (Washerless)
• 00190361020493: FacetFuse Screw, 6.0 x 25mm (Washerless)
• 00190361020486: FacetFuse Screw, 5.5 x 50mm (Washerless)
• 00190361020479: FacetFuse Screw, 5.5 x 45mm (Washerless)
• 00190361020462: FacetFuse Screw, 5.5 x 40mm (Washerless)