ANCHOR FS™ Facet Fixation System

GUDID 00643169099425

SCREW PFF0040 40MM FACET FIXATION ANCHOR

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00643169099425
• NIH Device Record Key: d1f204f9-7b23-42cb-994a-386b8abd7ba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCHOR FS™ Facet Fixation System
• Version Model Number: PFF0040
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169099425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101765

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2015-06-25

On-Brand Devices [ANCHOR FS™ Facet Fixation System]

• 00643169099425: SCREW PFF0040 40MM FACET FIXATION ANCHOR
• 00643169099418: SCREW PFF0035 35MM FACET FIXATION ANCHOR
• 00643169099401: SCREW PFF0030 30MM FACET FIXATION ANCHOR
• 00643169099395: SCREW PFF0025 25MM FACET FIXATION ANCHOR