FDA.reportPublic FDA data

Trigon

Primary DI
00810005668293
Brand
Trigon
Company
NVision Biomedical Technologies, Inc.
Model
WSC-25-30
Device description
Implant: 2.5mm dia x 30mm Fixation Screw Ti. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
Published
2021-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193414000Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.2020-02-25PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005668293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005668293008100056682938100056682930810005668293

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
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
00810135961264ToejackTJB-1001T-SG052026-07-24
00810135961271ToejackTJB-1000T-JBCG2026-07-24
00810135961752ToejackTJB-1000T-PDS2026-07-24
00810005666855TrigonLD-050004T-282024-02-22
00810005666862TrigonLD-050006T-282024-02-22
00810005666985TrigonLDP-2408-04102024-02-22
00810005666992TrigonLDP-2408-04082024-02-22
00810005667005TrigonLDP-2408-04062024-02-22
00810005667012TrigonLDP-2408-04042024-02-22
00810005667029TrigonLDP-2408-02102024-02-22
00810005667036TrigonLDP-2408-02082024-02-22
00810005667043TrigonLDP-2408-02062024-02-22
00810005667050TrigonLDP-2408-02042024-02-22
00810005667067TrigonLDP-2408-00102024-02-22
00810005667074TrigonLDP-2408-00082024-02-22
00810005667081TrigonLDP-2408-00062024-02-22
00810005667098TrigonLDP-2408-00042024-02-22
00810005667104TrigonLDP-2405-04082024-02-22
00810005667111TrigonLDP-2405-04062024-02-22
00810005667128TrigonLDP-2405-04042024-02-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08