FDA.reportPublic FDA data

NITINEX

Primary DI
00841731137531
Brand
NITINEX
Company
VILEX LLC
Model
SI-3030
Catalog number
SI-3030
Device description
NITINEX Staple Implant System, 30mm x 30mm, Sterile
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231493000NITINEX Memory Compression StapleVilex, LLC2023-08-11JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731137531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731137531008417311375318417311375310841731137531

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117502293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731135483TITANEX H4102026-05-15
00841731135568TITANEX K150-16SC2026-05-15
00841731137319TITANEX ART-KW2-1012026-05-15
00841731137906TITANEXK150-09S2026-05-15
00841731137913TITANEX TH-DRILL-202026-05-15
00841731137920TITANEX TH-DRILL-252026-05-15
00841731137937TITANEXTH-DEPTHTH-DEPTH2026-05-15
00841731137951TITANEX TH-DT72026-05-15
00841731137968TITANEX TH-DT82026-05-15
00841731138095TITANEX ART-KW2-1902026-05-15
00841731138101TITANEX ART-KWS-222026-05-15
00841731138118TITANEX ART-DTH-652026-05-15
00841731138125TITANEX ART-STP-492026-05-15
00841731138132TITANEX ART-DBC-492026-05-15
00841731138149TITANEX ART-RT-T252026-05-15
00841731138156TITANEX ART-VZO-152026-05-15
00841731140777TITANEX AZ-D130-262026-05-15
00841731140784TITANEX AZ-DT10-CR2026-05-15
00841731141910TITANEX AZ-D150-332026-05-15
00841731141927TITANEX AZ-DT15-CR2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238060MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238114MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06