TigerShark L

GUDID 00840996193054

TIGERSHARK L,OFFSET INSERTER

Choice Spine, LP

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 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 ID00840996193054
NIH Device Record Key3b184956-5c78-41f6-b5bb-ee52e1f3fe1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTigerShark L
Version Model NumberV070-1023
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
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
GS100840996193054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


[00840996193054]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

Devices Manufactured by Choice Spine, LP

00840996182119 - HARRIER-SA Lumbar Interbody System2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP
00840996150682 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5
00840996150699 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X6
00840996150705 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X7
00840996150712 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X8
00840996150729 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X9
00840996150736 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X10
00840996150743 - Acapella One2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X11

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