Tiger Shark System

GUDID 00840996181037

24Lx13H-6 DEG, TRIAL, TI SHARK TL

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996181037
NIH Device Record Key84f0418a-63f5-4211-8f04-f41f719d636c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiger Shark System
Version Model NumberP070-241306
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
GS100840996181037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

[00840996181037]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

On-Brand Devices [Tiger Shark System]

00840996173209TIGER SHARK,STERILE,STR,9X32X18,6 DEG
00840996173193TIGER SHARK,STERILE,STR,9X32X17,6 DEG
00840996173186TIGER SHARK,STERILE,STR,9X32X16,6 DEG
00840996173179TIGER SHARK,STERILE,STR,9X32X15,6 DEG
00840996173162TIGER SHARK,STERILE,STR,9X32X14,6 DEG
00840996173155TIGER SHARK,STERILE,STR,9X32X13,6 DEG
00840996173148TIGER SHARK,STERILE,STR,9X32X12,6 DEG
00840996173131TIGER SHARK,STERILE,STR,9X32X11,6 DEG
00840996173124TIGER SHARK,STERILE,STR,9X28X17,6 DEG
00840996173117TIGER SHARK,STERILE,STR,9X28X16,6 DEG
00840996173100TIGER SHARK,STERILE,STR,9X28X15,6 DEG
00840996173094TIGER SHARK,STERILE,STR,9X28X14,6 DEG
00840996173087TIGER SHARK,STERILE,STR,9X28X13,6 DEG
00840996173070TIGER SHARK,STERILE,STR,9X28X12,6 DEG
00840996173063TIGER SHARK,STERILE,STR,9X28X11,6 DEG
00840996173056TIGER SHARK,STERILE,STR,9X28X10,6 DEG
00840996173049TIGER SHARK,STERILE,STR,9X24X17,6 DEG
00840996173032TIGER SHARK,STERILE,STR,9X24X16,6 DEG
00840996173025TIGER SHARK,STERILE,STR,9X24X15,6 DEG
00840996173018TIGER SHARK,STERILE,STR,9X24X14,6 DEG
00840996173001TIGER SHARK,STERILE,STR,9X24X13,6 DEG
00840996172998TIGER SHARK,STERILE,STR,9X24X12,6 DEG
00840996172981TIGER SHARK,STERILE,STR,9X24X11,6 DEG
00840996172974TIGER SHARK,STERILE,STR,9X24X10,6 DEG
00840996172967TIGER SHARK,STERILE,STR,9X24X9,6 DEG
00840996169264TIGER SHARK,STERILE,LAT,40X22X15,6 DEG
00840996169110TIGER SHARK,STRAIGHT,TRIAL,9X24X17,6 DEG
00840996169103TIGER SHARK,STRAIGHT,TRIAL,9X24X16,6 DEG
00840996169097TIGER SHARK,STRAIGHT,TRIAL,9X24X15,6 DEG
00840996169080TIGER SHARK,STRAIGHT,TRIAL,9X24X14,6 DEG
00840996169073TIGER SHARK,STRAIGHT,TRIAL,9X24X13,6 DEG
00840996169066TIGER SHARK,STRAIGHT,TRIAL,9X24X12,6 DEG
00840996169059TIGER SHARK,STRAIGHT,TRIAL,9X24X11,6 DEG
00840996169042TIGER SHARK,STRAIGHT,TRIAL,9X24X10,6 DEG
00840996169035TIGER SHARK,STRAIGHT,TRIAL,9X24X9,6 DEG
00840996169028TIGER SHARK,STRAIGHT,TRIAL,9X24X8,6 DEG
00840996169011TIGER SHARK,STRAIGHT,TRIAL,9X24X7,6 DEG
00840996169004TIGER SHARK,STRAIGHT,TRIAL,9X24X6,6 DEG
00840996168991TIGER SHARK,STRAIGHT,TRIAL,9X28X17,6DEG
00840996168984TIGER SHARK,STRAIGHT,TRIAL,9X28X16,6 DEG
00840996168977TIGER SHARK,STRAIGHT,TRIAL,9X28X15,6 DEG
00840996168960TIGER SHARK,STRAIGHT,TRIAL,9X28X14,6 DEG
00840996168953TIGER SHARK,STRAIGHT,TRIAL,9X28X13,6 DEG
00840996168946TIGER SHARK,STRAIGHT,TRIAL,9X28X12,6 DEG
00840996168939TIGER SHARK,STRAIGHT,TRIAL,9X28X11,6 DEG
00840996168922TIGER SHARK,STRAIGHT,TRIAL,9X28X10,6 DEG
00840996168915TIGER SHARK,STRAIGHT,TRIAL,9X28X9,6 DEG
00840996168908TIGER SHARK,STRAIGHT,TRIAL,9X28X8,6 DEG
00840996168892TIGER SHARK,STRAIGHT,TRIAL,9X28X7,6 DEG
00840996168885TIGER SHARK,STRAIGHT,TRIAL,9X28X6,6 DEG
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.