Centerline Thoracolumbar Spinal System 6475-025

GUDID 00190837022037

4.75mm x 25mm Pre-Lordosed Rod, CoCr

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837022037
NIH Device Record Key5c2c1dbf-a1be-4f92-b350-50d05fe6bd65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterline Thoracolumbar Spinal System
Version Model Number6475-025
Catalog Number6475-025
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 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
GS100190837022037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837022037]

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 [Centerline Thoracolumbar Spinal System]

001908370024594085-95-41
001908370024424085-90-41
001908370024354085-85-41
001908370024284085-80-41
001908370024114085-75-41
001908370024044085-70-41
001908370023984085-65-41
001908370023814085-60-41
001908370023744085-55-41
001908370023674085-50-41
001908370023504085-45-41
001908370023434085-40-41
001908370023364085-35-41
001908370023294085-30-41
001908370023124085-25-41
001908370023054085-115-41
001908370022994085-105-41
001908370022824075-95-41
001908370022754075-90-41
001908370022684075-85-41
001908370022514075-80-41
001908370022444075-75-41
001908370022374075-70-41
001908370022204075-65-41
001908370022134075-60-41
001908370022064075-125-41
001908370021904075-115-41
001908370021834075-105-41
001908370021764065-95-41
001908370021694065-85-41
001908370021524065-75-41
001908370021454065-65-41
001908370021384065-125-41
001908370021214065-115-41
001908370021144065-105-41
001908370021074060-55-41
001908370020914060-50-41
001908370020844060-45-41
001908370020774060-40-41
001908370020604060-35-41
001908370020534060-30-41
001908370020464060-25-41
001908370020394055-25-41
001908370020224050-55-41
001908370020154050-50-41
001908370020084050-45-41
001908370019954050-40-41
001908370019884050-35-41
001908370019714050-30-41
001908370019644050-25-41

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