Impact PEEK Union Nail System
Nvision Biomedical Technologies
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011301313 | 3011301313 | NVISION BIOMEDICAL TECHNOLOGIES, INC | 1 | Y | 2026-01-01 | 12449 Silicon Dr San Antonio TX US 78249 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810005666855 | Trigon - 5mm (0° Sagittal 4° Transverse) 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005666862 | Trigon - 5mm (0° Sagittal 6° Transverse) 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005666985 | Trigon - 8mm (4° Sagittal 10° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005666992 | Trigon - 8mm (4° Sagittal 8° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005667005 | Trigon - 8mm (4° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005667012 | Trigon - 8mm (4° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005667029 | Trigon - 8mm (2° Sagittal 10° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| 00810005667036 | Trigon - 8mm (2° Sagittal 8° 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. | 210-545-3713 | diana@nvisionbiomed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 178336 | 1043326744 | K253423 | ToeJack MIS Bunion System | HRS | 2025-11-18 |
| 178336 | 2009141418 | K250646 | Impact PEEK Union Nail System | HTY | 2025-06-11 |
| 178336 | 1922713739 | K243231 | Trigon PEEK HA Wedges | PLF | 2024-11-08 |
| 178336 | 1687571204 | K242896 | Caliber Intramedullary Fixation System | HWC | 2025-02-05 |
| 178336 | 1612753645 | K240250 | 3D Printed PEEK Interbody System | MAX | 2024-09-17 |
| 178336 | 1678059981 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | PLF | 2024-01-26 |
| 178336 | 1858342312 | K231453 | SnapHammer Hammertoe Correction System | HWC | 2024-02-16 |
| 178336 | 1577725291 | K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | PLF | 2022-12-01 |
| 178336 | 1467646533 | K222015 | Integral Titanium Cervical Interbody | ODP | 2023-07-05 |
| 178336 | 1649362954 | K220197 | Trigon HA Wedge Fixation System | PLF | 2022-02-23 |
| 178336 | 1176923325 | K213421 | Vector® Hammertoe Correction System | HWC | 2021-11-19 |
| 178336 | 1830845334 | K211650 | The Radian MIS Bunion System | HRS | 2021-11-24 |
| 178336 | 1659004310 | K210424 | Quantum Anterior Cervical Plate | KWQ | 2021-10-22 |
| 178336 | 1442513658 | K202657 | Javelin Tailor's Bunion Fixation System | HRS | 2020-12-14 |
| 178336 | 1289695785 | K201850 | Vector Hammertoe Correction System | HWC | 2020-08-04 |
| 178336 | 1180951484 | K200914 | Healix Compression Screw System | HWC | 2020-05-05 |
| 178336 | 1827564091 | K200428 | Multi-Drive Interference Screw System | MBI | 2020-11-10 |
| 178336 | 1741246327 | K193645 | nva, nvp, and nvt | MAX | 2020-01-13 |
| 178336 | 1974594616 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | PLF | 2020-02-25 |
| 178336 | 1559406247 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | PLF | 2019-12-23 |
| 178336 | 2028435702 | K190380 | nvc | ODP | 2019-03-21 |
| 178336 | 1525864231 | K183055 | Vector Hammertoe Correction System | HWC | 2019-02-19 |
| 178336 | 1188753095 | K182949 | Healix™ Compression Screw System | HWC | 2018-12-04 |
| 178336 | 1268147912 | K182943 | VERTEX Nitinol Staple System | JDR | 2019-04-04 |
| 178336 | 1004295049 | K180458 | FOCUS Pedicle Screw System | NKB | 2018-04-17 |
| 178336 | 1691842512 | K173091 | Boundary Anterior Lumbar Buttress Plate | KWQ | 2017-12-06 |
| 178336 | 1234010720 | K170074 | nvc | ODP | 2017-01-24 |
| 178336 | 1743004811 | K162426 | nva, nvp, and nvt | MAX | 2016-09-29 |
| 178336 | 1051650944 | K161524 | Tangis Anterior Cervical Plate | KWQ | 2016-09-02 |
| 178336 | 1926510214 | K142594 | nva, nvp, nvt | MAX | 2014-11-28 |
| 178336 | 1584091262 | K142328 | nvc | ODP | 2014-12-23 |
| 178336 | 1114991854 | ||||
| 178336 | 1142481306 | ||||
| 178336 | 1176835741 | ||||
| 178336 | 1215086719 | ||||
| 178336 | 1256140705 | ||||
| 178336 | 1286329936 | ||||
| 178336 | 1306095919 | ||||
| 178336 | 1319402742 | ||||
| 178336 | 1532001481 | ||||
| 178336 | 1560314429 | ||||
| 178336 | 1584893023 | ||||
| 178336 | 1665689343 | ||||
| 178336 | 1745628825 | ||||
| 178336 | 1932111467 | ||||
| 178336 | 1992589691 | ||||
| 178336 | 2019553385 | ||||
| 178336 | 2035958244 | ||||
| 178336 | 2063174435 |
Nvision Biomedical Technologies
Nvision Biomedical Technologies
Nvision Biomedical Technologies
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, LLC
Nvision Biomedical Technologies, Inc.
Nvision Biomedical Technologies, LLC
Nvision Biomedical Technologies, LLC
Nvision Biomedical Technologies, LLC
Nvision Biomedical Technologies, LLC
Nvision Biomedical Technologies, LLC
NVISION BIOMEDICAL TECHNOLOGIES, LLC
NVISION BIOMEDICAL TECHNOLOGIES, LLC
NVISION BIOMEDICAL TECHNOLOGIES, LLC
NVISION BIOMEDICAL TECHNOLOGIES, LLC
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