FDA.reportPublic FDA data

TiGER SHARK Interbody Fusion System

Primary DI
00840996176804
Brand
TiGER SHARK Interbody Fusion System
Company
Choice Spine, LP
Model
D070-DS014120708
Device description
Parallel 14X12,0 deg Dual trials 7&8H
Published
2019-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

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
00840996176804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996176804008409961768048409961768040840996176804

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(865)246-3333INFO@CHOICESPINE.COM

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
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22