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 | |
|---|---|---|---|
| 00810005667227 | Trigon - Instrument: Lapidus wedge screw sleeve assembly. 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. | +1 210-598-5648 | anikajosephsmith@nvisionbiomed.com |
| 00810005668163 | Vertex - Instrument-Vertex Staple Placement Pin: The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. | 210-545-3713 | anikajosephsmith@nvisionbiomed.com |
| 00810135963374 | Impact - PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy. | 2105985938 | denisealva@nvisionbiomed.com |
| 00810135963404 | Impact - Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy. | 2105985938 | denisealva@nvisionbiomed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 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 |
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| 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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