Trigon
- Primary DI
- 00810005667098
- Brand
- Trigon
- Company
- NVision Biomedical Technologies, Inc.
- Model
- LDP-2408-0004
- Device description
- 8mm (0° Sagittal 4° 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#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K220197 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810005667098 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810005667098 | 00810005667098 | 810005667098 | 0810005667098 |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Height | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| 210-545-3713 | diana@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
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|---|---|---|---|---|
| 00810005663762 | Toejack | TB-30-20L | 2026-07-29 | |
| 00810005663779 | Toejack | TB-30-22L | 2026-07-29 | |
| 00810005665711 | Toejack | TB-30-18L | 2026-07-29 | |
| 00810005668828 | Trigon | TB-30-18N | 2026-07-29 | |
| 00810005668835 | ToeJack | TB-30-20N | 2026-07-29 | |
| 00810005668842 | Toejack | TB-30-22N | 2026-07-29 | |
| 00810135961196 | ToeJack | TJB-30-30 | 2026-07-29 | |
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| 00810135961769 | Toejack | TJB-30-14HL | 2026-07-29 | |
| 00810135961776 | Toejack | TJB-30-16HL | 2026-07-29 | |
| 00810135961783 | Toejack | TJB-30-18HL | 2026-07-29 | |
| 00810135961790 | Toejack | TJB-30-20HL | 2026-07-29 | |
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