Company · US
Nvision Biomedical Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 9 |
| PLF | Bone Wedge | 7 |
| HRS | Plate, Fixation, Bone | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| HTY | Pin, Fixation, Smooth | 2 |
| ETN | Stimulator, Nerve | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K261961 | Ntegrate Threaded Nail System Nvision Biomedical Technologies | HWC |
| Sep 18, 2026 | K262098 | EnHAnce PEEK Bunion System Nvision Biomedical Technologies | HRS |
| Apr 1, 2026 | K253718 | enHAnce PEEK Bunion System Nvision Biomedical Technologies, Inc. | HRS |
| Mar 25, 2026 | K260291 | Vortex5 Tailor's Bunion Correction System Nvision Biomedical Technologies, Inc. | HRS |
| Nov 18, 2025 | K253423 | ToeJack MIS Bunion System Nvision Biomedical Technologies, Inc. | HRS |
| Sep 19, 2025 | K252657 | Impact PEEK Union Nail System Nvision Biomedical Technologies, Inc. | HTY |
| Jun 11, 2025 | K250646 | Impact PEEK Union Nail System Nvision Biomedical Technologies | HTY |
| Apr 2, 2025 | K250613 | SnapHammer Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
| Feb 5, 2025 | K242896 | Caliber Intramedullary Fixation System Nvision Biomedical Technologies | HWC |
| Nov 8, 2024 | K243231 | Trigon PEEK HA Wedges Nvision Biomedical Technologies | PLF |
| Sep 17, 2024 | K240250 | 3D Printed PEEK Interbody System Nvision Biomedical Technologies, Inc. | MAX |
| Feb 16, 2024 | K231453 | SnapHammer Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
| Jan 26, 2024 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies | PLF |
| Oct 6, 2023 | K230853 | EARP Nerve Cuff Electrode Nvision Biomedical Technologies, Inc. | ETN |
| Jul 5, 2023 | K222015 | Integral Titanium Cervical Interbody Nvision Biomedical Technologies, Inc. | ODP |
| Dec 1, 2022 | K223226 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Apr 28, 2022 | K212477 | EARP Interbody System Nvision Biomedical Technologies, Inc. | MAX |
| Feb 23, 2022 | K220197 | Trigon HA Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Nov 24, 2021 | K211650 | The Radian MIS Bunion System Nvision Biomedical Technologies, Inc. | HRS |
| Nov 19, 2021 | K213421 | Vector® Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
| Oct 22, 2021 | K210424 | Quantum Anterior Cervical Plate Nvision Biomedical Technologies, Inc. | KWQ |
| Dec 21, 2020 | K203445 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Dec 14, 2020 | K202657 | Javelin Tailor's Bunion Fixation System Nvision Biomedical Technologies, Inc. | HRS |
| Nov 10, 2020 | K200428 | Multi-Drive Interference Screw System Nvision Biomedical Technologies, Inc. | MBI |
| Aug 4, 2020 | K201850 | Vector Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
| May 5, 2020 | K200914 | Healix Compression Screw System Nvision Biomedical Technologies, Inc. | HWC |
| Feb 25, 2020 | K193414 | Trigon HA Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Jan 13, 2020 | K193645 | nva, nvp, and nvt Nvision Biomedical Technologies, Inc. | MAX |
| Dec 23, 2019 | K192645 | Trigon Ti Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. | PLF |
| Apr 4, 2019 | K182943 | VERTEX Nitinol Staple System Nvision Biomedical Technologies, LLC | JDR |
| Mar 21, 2019 | K190380 | nvc Nvision Biomedical Technologies, Inc. | ODP |
| Feb 19, 2019 | K183055 | Vector Hammertoe Correction System Nvision Biomedical Technologies, LLC | HWC |
| Dec 4, 2018 | K182949 | Healix Compression Screw System Nvision Biomedical Technologies, LLC | HWC |
| Apr 17, 2018 | K180458 | FOCUS Pedicle Screw System Nvision Biomedical Technologies, LLC | NKB |
| Dec 6, 2017 | K173091 | Boundary Anterior Lumbar Buttress Plate Nvision Biomedical Technologies, LLC | KWQ |
| Jan 24, 2017 | K170074 | nvc Nvision Biomedical Technologies, LLC | ODP |
| Sep 29, 2016 | K162426 | nva, nvp, and nvt Nvision Biomedical Technologies, LLC | MAX |
| Sep 2, 2016 | K161524 | Tangis Anterior Cervical Plate Nvision Biomedical Technologies, LLC | KWQ |
| Dec 23, 2014 | K142328 | nvc Nvision Biomedical Technologies, LLC | ODP |
| Nov 28, 2014 | K142594 | nva, nvp, nvt Nvision Biomedical Technologies, LLC | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||