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 | |
|---|---|---|---|
| 00814008029723 | FOCUS - Rod, MIS, Lordotic 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 210-545-3713 | Diana@nvisionbiomed.com |
| 00814008029730 | FOCUS - Rod, MIS, Lordotic 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 210-545-3713 | Diana@nvisionbiomed.com |
| 00814008029747 | FOCUS - Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 210-545-3713 | diana@nvisionbiomed.com |
| 00814008029754 | FOCUS - Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 210-545-3713 | diana@nvisionbiomed.com |
| 00814008029761 | Watershed Idea Foundry - Decoder Ring - Sample Product, do not implant. | 210-545-3713 | diana@nvisionbiomed.com |
| 00814008029808 | Boundary - Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications. | 210-545-3713 | diana@nvisionbiomed.com |
| 00814008029815 | FOCUS - Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 210-545-3713 | diana@nvisionbiomed.com |
| 00814008029822 | FOCUS - Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion. | 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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