Kinetic-SL Dynamic Anterior Cervical Plate System

GUDID 00190837005344

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837005344
NIH Device Record Key64bbfb49-3805-40d0-980a-309b97962eba
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinetic-SL Dynamic Anterior Cervical Plate System
Version Model Number1282-044
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100190837005344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


[00190837005344]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-10

On-Brand Devices [Kinetic-SL Dynamic Anterior Cervical Plate System]

001908370056581285-111
001908370056411285-101
001908370056341284-091
001908370056271284-083
001908370056101284-073
001908370056031284-067
001908370054431283-067
001908370054361283-065
001908370054291283-061
001908370054121283-059
001908370054051283-055
001908370053991283-053
001908370053821282-052
001908370053751282-050
001908370053681282-048
001908370053511282-046
001908370053441282-044
001908370053371282-042
001908370053201282-040
001908370053131282-038
001908370053061282-036
001908370052901282-034
001908370052831281-036
001908370052761281-034
001908370052691281-032
001908370052521281-030
001908370052451281-028
001908370052381281-026
001908370052211281-024
001908370052141281-022
001908370052071281-021
00190837037383Kinetic SL Single Barrel Snap-On Drill/Tap Guide, Distal
00190837037376Kinetic SL Single Barrel Snap-On Drill/Tap Guide, Intermedia
00190837037291Custom Cervical Screw Driver
00190837037468SL FT Variable Screw - 24mm length, D=4mm
00190837037451SL FT Variable Screw - 22mm length, D=4mm
00190837037444SL FT Variable Screw - 20mm length, D=4mm
00190837037437Kinetic-SL Fixation Pin
00190837037420SL Dynamic Distractor 1mm
00190837037413Pro-Link Screwdriver, Straight Tapered Hex, AO Power
00190837037406NEO-UL Hexalobe T10 Screwdriver, AO Power
00190837037390ACPS Hexalobe T10 Screwdriver, AO Power
00190837037369Cervical Screw Driver, AO Drive
00190837037352Solstice Adjustable Drill Guide
00190837037345Cervical Screw Driver, Spin Cap Handle
00190837037338Drill Guide
00190837037321Custom 3.5mm Rod Inserter, Rachet Style
00190837037314Locking Cap Final Torque Driver Shaft, Short
00190837037307Temporary Fixation Pin
00190837037284Micro Variable Angle Drill Guide

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