FS3 Facet Screw Spinal System 2016-0227

GUDID 00190837041397

18mm Reamer Guide

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837041397
• NIH Device Record Key: 665b5379-35fc-469d-90eb-3c53ac38951c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FS3 Facet Screw Spinal System
• Version Model Number: 2016-0227
• Catalog Number: 2016-0227
• Company DUNS: 183641617
• Company Name: Life Spine, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837041397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090865

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[00190837041397]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [FS3 Facet Screw Spinal System]

• 00190837003760: 144-45-45
• 00190837003753: 144-45-40
• 00190837003746: 144-45-35
• 00190837003739: 144-45-30
• 00190837003722: 144-45-25
• 00190837041144: DILATION TUBE 2
• 00190837041519: Cannulated Reamer, Ø6.25mm X 16mm, Tapered Tip
• 00190837041502: FS3 Dilation Tube, #4, Radiopaque
• 00190837041496: FS3 Stab-N-Grab Driver, T20
• 00190837041489: Facet Screw Driver, Mid Length with Flats
• 00190837041472: Cannulated Reamer, 6.25mm x 16mm, Tapered Tip
• 00190837041465: Cannulated Step Drill
• 00190837041458: FS3 Cannulated Drill, AO Drive, Short
• 00190837041441: FS3 Dilation Tube, #4, with Teeth
• 00190837041434: MIS Tap, Short, 4.5mm, Depth Marks
• 00190837041427: Cannulated Drill, 1/4" sq., Short, Depth Marks
• 00190837041410: Facet Screw Driver, Short
• 00190837041403: 20mm Reamer Guide
• 00190837041397: 18mm Reamer Guide
• 00190837041380: 16mm Reamer Guide
• 00190837041373: 20mm Reamer
• 00190837041366: 18mm Reamer
• 00190837041359: 16mm Reamer
• 00190837041342: Reamer Driver
• 00190837041335: Cannulated Reamer, 6.25mm x 16mm
• 00190837041328: Puppet Leg Caspar Distractor
• 00190837041311: Pedicle Marker, Threaded 25mm
• 00190837041304: TLIF Distractor
• 00190837041298: Facet Screw, 4.5mm x 24mm
• 00190837041281: Facet Screw, 4.5mm x 22mm
• 00190837041274: FS3 Dissector
• 00190837041267: Self Retaining Driver, Facet Screw
• 00190837041250: Cannulated Drill, Trephine Tip, Facet Screw
• 00190837041243: Cannulated Drill, Tri-Flat, Facet Screw
• 00190837041236: Access Needle, 11 GA
• 00190837041229: Facet Screw Caddy
• 00190837041212: Access Needle Sheath
• 00190837041205: Hexalobe Driver
• 00190837041199: Facet Screw Driver
• 00190837041182: Cannulated Drill, Facet Screw
• 00190837041175: Facet Screw Driver, Short
• 00190837041168: #4 Dilation Tube, Stainless Steel
• 00190837041151: DILATION TUBE 4
• 00190837041137: K-Wire Installer
• 00190837041120: FS3 - Facet Screw System
• 00190837041113: Empty Facet Screw Instruemtation Tray