Product code PLF
- Device name
- Bone Wedge
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026-02-19 |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025-10-17 |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025-09-25 |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 |
| K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017-05-16 |
| K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017-04-03 |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015-08-12 |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | 2015-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810005666992 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667166 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667159 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667142 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667135 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667128 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667111 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667104 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667098 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667081 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667067 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667050 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667043 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667036 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667029 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667012 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667005 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005666985 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667074 | Trigon | NVision Biomedical Technologies, Inc. | 2024-02-22 |
| 00810005667777 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667760 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667753 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667746 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667739 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667722 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667715 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667708 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667692 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667685 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |
| 00810005667678 | Trigon | NVision Biomedical Technologies, Inc. | 2021-01-29 |