FDA.reportPublic FDA data

Triton

Primary DI
00840996184823
Brand
Triton
Company
Choice Spine, LP
Model
S-QT10-0865
Device description
Triton,screws,S,8x65mm
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac joint fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211449000Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC2021-08-31OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996184823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996184823008409961848238409961848230840996184823

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags#

DUNS number
078293017
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840996182119HARRIER-SA Lumbar Interbody SystemY070-00432024-02-26
00840996150682Acapella One05-099-05-14052024-02-24
00840996150699Acapella One05-099-05-14062024-02-24
00840996150705Acapella One05-099-05-14072024-02-24
00840996150712Acapella One05-099-05-14082024-02-24
00840996150729Acapella One05-099-05-14092024-02-24
00840996150736Acapella One05-099-05-14102024-02-24
00840996150743Acapella One05-099-05-14112024-02-24
00840996150750Acapella One05-099-05-14122024-02-24
00840996150767Acapella One05-099-05-16052024-02-24
00840996150774Acapella One05-099-05-16062024-02-24
00840996150781Acapella One05-099-05-16072024-02-24
00840996150798Acapella One05-099-05-16082024-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841193127996T-FIX™3Dsi Joint Fusion SystemCutting Edge Spine, LLCOUR2026-03-24
00810131882082TiLink InSite Disposable KitSURGENTEC, LLCOUR2026-03-09
00810131882730Joint Fusion Office KitSURGENTEC, LLCOUR2026-03-09
00810131882204TiLink-P Instrument Removal Tool - MetalSURGENTEC, LLCOUR2026-02-25
00810055525768iFuse INTRA Ti ImplantSi-Bone Inc.OUR2026-02-17
00889929072189NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-02-10
M719GSIX122L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX122S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1230SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1240SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1250SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200M0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200XL0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX2110SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3000SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3010SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1131050SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1131150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1160SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1180SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190550SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190650SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190750SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27