FDA.reportPublic FDA data

Tiger Shark System

Primary DI
00840996181105
Brand
Tiger Shark System
Company
Choice Spine, LP
Model
P070-281206
Device description
28Lx12H-6 DEG, TRIAL, TI SHARK TL
Published
2023-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172816000TiGer Shark™ SystemChoicespine, LP2018-01-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996181105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996181105008409961811058409961811050840996181105

GMDN Terms#

Term, Definition table
TermDefinition
Intervertebral-body internal spinal fixation systemA group of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the centre of each plate, and a braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078293017
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840996183154Ambassador05-109-18-00272023-02-03
00810211101256THUNDERBOLTM070-02312026-02-13
00840996176552BOOMERANGBT20-D45132026-01-15
00840996176569BOOMERANGBT20-D45152026-01-15
00840996176576BoomerangBT20-D45172026-01-15
00840996176583BOOMERANGB070-00002026-01-15
00840996176590BOOMERANGB070-D0102026-01-15
00840996176606BoomerangB070-00012026-01-15
00840996176392VEo LateralV070-00902022-11-16
00840996176408VEo LateralV070-00912022-11-16
00840996176415VEo LateralV070-00922022-11-16
00840996176422VEo LateralV070-00932022-11-16
00840996176125TiGER SHARK Interbody Fusion SystemS-PT36-240962019-01-05
00840996176132TiGER SHARK Interbody Fusion SystemS-PT36-241062019-01-05
00840996176149TiGER SHARK Interbody Fusion SystemS-PT36-241162019-01-05
00840996176156TiGER SHARK Interbody Fusion SystemS-PT36-241262019-01-05
00840996176163TiGER SHARK Interbody Fusion SystemS-PT36-241362019-01-05
00840996176170TiGER SHARK Interbody Fusion SystemS-PT36-241462019-01-05
00840996176187TiGER SHARK Interbody Fusion SystemS-PT36-241562019-01-05
00840996176194TiGER SHARK Interbody Fusion SystemS-PT36-241662019-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
00190776433666MillenniumAvalign Technologies, Inc.LXH2026-10-07
00810017915972T-Handle, 1/4" Sq, RatchetingELEVATION SPINE, INC.LXH2026-10-07
00810017915996Torque Limiting Expansion Driver Handle, 3.0NmELEVATION SPINE, INC.LXH2026-10-07
00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
10888857615694CHESAPEAKE® Stabilization SystemVB Spine LLCLXH2026-09-23