Dyna-Link Ti

GUDID 00190837142834

Life Spine, Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00190837142834
NIH Device Record Keybd00cb9c-8e31-44df-98a6-d2dd0db2e53c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna-Link Ti
Version Model NumberL125-705
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
GS100190837142834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


[00190837142834]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

On-Brand Devices [Dyna-Link Ti]

00190837142858L125-707
00190837142841L125-706
00190837142834L125-705
00190837142827L125-697
00190837142810L125-691
00190837142803L125-690
00190837142797L125-684
00190837142780L125-683
00190837142773L125-615
00190837142766L125-173
00190837142759L125-1054
00190837142742L125-1052
00190837142735L125-1050
00190837142728L125-1048
00190837142711L125-1038
00190837142704L125-1036
00190837142698L125-1034
00190837142681L125-1032
00190837142674L125-1022
00190837142667L125-1020
00190837142650L125-1018
00190837142643L125-1016
00190837142636L125-1006
00190837142629L125-1004
00190837142612L125-1002
00190837142605L125-1000
00190837142599L114-882-2
00190837142582L114-882-1
00190837142575L114-881-5
00190837142568L114-881-4
00190837142551L114-881-3
00190837142544L114-881-2
00190837142537L114-881-1
00190837143039L125-700
00190837143022L125-678
00190837143015L125-677
00190837143008L125-676
00190837142995L125-674
00190837142988L125-673
00190837142971L125-672
00190837142964L125-671
00190837142957L125-638
00190837142940L148-402
00190837142933L125-799
00190837142926L125-798
00190837142919L125-797
00190837142902L125-725
00190837142896L125-724
00190837142889L125-723
00190837142872L125-722

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