Centerline Thoracolumbar Spinal System 5550-095

GUDID 00190837065003

Cobalt Chrome Rod, Straight

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837065003
NIH Device Record Key69505cac-e8d7-4912-9bba-6716e7882e81
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterline Thoracolumbar Spinal System
Version Model Number5550-095
Catalog Number5550-095
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
GS100190837065003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837065003]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

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.