NEO SL/Kinetic SL Anterior Cervical Plate System

GUDID 00190837005757

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837005757
NIH Device Record Key6a2f2e0b-8d10-4d9d-8a62-5c4da71547e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEO SL/Kinetic SL Anterior Cervical Plate System
Version Model Number306-018
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
GS100190837005757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837005757]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-14

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

00190837005757306-018
00190837005740306-016
00190837005733306-014
00190837005726306-012
00190837005719306-010
00190837005702305-018
00190837005696305-016
00190837005689305-014
00190837005672305-012
00190837005665305-010
00190837005597303-018
00190837005580303-016
00190837005573303-014
00190837005566303-012
00190837005559303-010
00190837005542302-018
00190837005535302-016
00190837005528302-014
00190837005511302-012
00190837005504302-010
00190837005498301-018
00190837005481301-016
00190837005474301-014
00190837005467301-012
00190837005450301-010
00190837024413NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 18mm
00190837024406NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 16mm
00190837024390NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 14mm
00190837024383NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 12mm
00190837024376NEO-SL/KINETIC-SL Bone Screw, Emergency, Variable Angle, Sharp Tip, 4.3mm x 10mm

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