Centerline Thoracolumbar Spinal System 148-193

GUDID 00190837064075

Awl with Stop

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837064075
NIH Device Record Keya83613c2-7438-4ed4-bd55-3d64f8d7e37a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterline Thoracolumbar Spinal System
Version Model Number148-193
Catalog Number148-193
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 Usefalse
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
GS100190837064075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837064075]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.