ProLink Barb

GUDID 00190837156756

Life Spine, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00190837156756
NIH Device Record Keyc6aebc38-1338-4182-88b8-259865c5b6aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameProLink Barb
Version Model Number129-023
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
GS100190837156756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


[00190837156756]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-25
Device Publish Date2024-09-17

On-Brand Devices [ProLink Barb]

00190837156725129-020
00190837156787129-026
00190837156770129-025
00190837156763129-024
00190837156756129-023
00190837156749129-022
00190837156732129-021

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