Centerline Thoracolumbar Spinal System 4553-200

GUDID 00190837064969

Straight Spinal Rod, 5.5mmx 200mm (Bulleted)

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837064969
NIH Device Record Key4faeaa23-b696-4c53-8d5d-b3086f296123
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterline Thoracolumbar Spinal System
Version Model Number4553-200
Catalog Number4553-200
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
GS100190837064969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837064969]

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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