NEO SL Anterior Cervical Plate System

GUDID 00190837008185

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 ID00190837008185
NIH Device Record Key359f2e2f-4155-433a-bfaa-3116b25d2bfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEO SL Anterior Cervical Plate System
Version Model NumberSL2-044
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
GS100190837008185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


[00190837008185]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

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

00190837008383SL5-110
00190837008376SL5-105
00190837008369SL5-100
00190837008352SL5-095
00190837008345SL4-090
00190837008338SL4-086
00190837008321SL4-082
00190837008314SL4-078
00190837008307SL4-074
00190837008291SL3-074
00190837008284SL3-070
00190837008277SL3-067
00190837008260SL3-064
00190837008253SL3-061
00190837008246SL3-058
00190837008239SL3-055
00190837008222SL3-052
00190837008215SL2-050
00190837008208SL2-048
00190837008192SL2-046
00190837008185SL2-044
00190837008178SL2-042
00190837008161SL2-040
00190837008154SL2-038
00190837008147SL2-036
00190837008130SL2-034
00190837008123SL1-034
00190837008116SL1-032
00190837008109SL1-030
00190837008093SL1-028
00190837008086SL1-026
00190837008079SL1-024
00190837008062SL1-022
00190837008055SL1-020

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