FS3 Facet Screw Spinal System 2016-0223

GUDID 00190837041359

16mm Reamer

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837041359
NIH Device Record Keyaaae5cf4-d162-4af1-a200-e7a8477145e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFS3 Facet Screw Spinal System
Version Model Number2016-0223
Catalog Number2016-0223
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837041359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837041359]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [FS3 Facet Screw Spinal System]

00190837003760144-45-45
00190837003753144-45-40
00190837003746144-45-35
00190837003739144-45-30
00190837003722144-45-25
00190837041144DILATION TUBE 2
00190837041519Cannulated Reamer, Ø6.25mm X 16mm, Tapered Tip
00190837041502FS3 Dilation Tube, #4, Radiopaque
00190837041496FS3 Stab-N-Grab Driver, T20
00190837041489Facet Screw Driver, Mid Length with Flats
00190837041472Cannulated Reamer, 6.25mm x 16mm, Tapered Tip
00190837041465Cannulated Step Drill
00190837041458FS3 Cannulated Drill, AO Drive, Short
00190837041441FS3 Dilation Tube, #4, with Teeth
00190837041434MIS Tap, Short, 4.5mm, Depth Marks
00190837041427Cannulated Drill, 1/4" sq., Short, Depth Marks
00190837041410Facet Screw Driver, Short
0019083704140320mm Reamer Guide
0019083704139718mm Reamer Guide
0019083704138016mm Reamer Guide
0019083704137320mm Reamer
0019083704136618mm Reamer
0019083704135916mm Reamer
00190837041342Reamer Driver
00190837041335Cannulated Reamer, 6.25mm x 16mm
00190837041328Puppet Leg Caspar Distractor
00190837041311Pedicle Marker, Threaded 25mm
00190837041304TLIF Distractor
00190837041298Facet Screw, 4.5mm x 24mm
00190837041281Facet Screw, 4.5mm x 22mm
00190837041274FS3 Dissector
00190837041267Self Retaining Driver, Facet Screw
00190837041250Cannulated Drill, Trephine Tip, Facet Screw
00190837041243Cannulated Drill, Tri-Flat, Facet Screw
00190837041236Access Needle, 11 GA
00190837041229Facet Screw Caddy
00190837041212Access Needle Sheath
00190837041205Hexalobe Driver
00190837041199Facet Screw Driver
00190837041182Cannulated Drill, Facet Screw
00190837041175Facet Screw Driver, Short
00190837041168#4 Dilation Tube, Stainless Steel
00190837041151DILATION TUBE 4
00190837041137K-Wire Installer
00190837041120FS3 - Facet Screw System
00190837041113Empty Facet Screw Instruemtation Tray

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