FDA.reportPublic FDA data

Trigon

Primary DI
00810005667081
Brand
Trigon
Company
NVision Biomedical Technologies, Inc.
Model
LDP-2408-0006
Device description
8mm (0° Sagittal 6° Transverse) PEEK Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
Published
2024-02-22
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
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220197000Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.2022-02-23PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005667081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005667081008100056670818100056670810810005667081

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric osteotomy fusion cage, non-customizedA non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0

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
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00810005663779ToejackTB-30-22L2026-07-29
00810005665711ToejackTB-30-18L2026-07-29
00810005668828TrigonTB-30-18N2026-07-29
00810005668835ToeJackTB-30-20N2026-07-29
00810005668842ToejackTB-30-22N2026-07-29
00810135961196ToeJackTJB-30-302026-07-29
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00810135961233ToejackTJB-1001T-DPG2026-07-29
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00810135961769ToejackTJB-30-14HL2026-07-29
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00810135961790ToejackTJB-30-20HL2026-07-29
00810135961806ToejackTJB-30-22HL2026-07-29
00810135963121ToeJack Bunion Correction SystemTJB-1000C-1052026-07-29
00810135965088ToeJack Bunion Correction SystemTJB-1000C-1042026-07-29

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