Identity
- Trade Name
- Trigon FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Implant: 2.5mm dia x 14mm 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. FDA UDI
- Model / Reference
- WSC-25-14 FDA UDI
- Description
- Implant: 2.5mm dia x 14mm 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810005668217 FDA UDI
- 510(k) Number
- K193414 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.5 Millimeter FDA UDILength — 14 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Trigon by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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Cleared under the same submission
K193414 also covers:
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI d863a340-4ddb-4f1e-9f36-c504c39122c6 36 fields · synced Jun 1, 2026