FDA Product Code
FDA Product Code PLF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252733 | ATLAS Expandable Osteotomy Wedge System | MiRus, LLC | 2026-02-19 | Traditional | PDF ↗ |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025-10-17 | Traditional | PDF ↗ |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025-09-25 | Traditional | PDF ↗ |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 | Abbreviated | PDF ↗ |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 | Special | PDF ↗ |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 | Special | PDF ↗ |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 | Traditional | PDF ↗ |
| K223226 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 | Special | PDF ↗ |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 | Special | PDF ↗ |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 | Traditional | PDF ↗ |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 | Special | PDF ↗ |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 | Traditional | PDF ↗ |
| K192645 | Trigon Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 | Traditional | PDF ↗ |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 | Traditional | PDF ↗ |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017-05-16 | Special | PDF ↗ |
| K162241 | TITAN 3-D Wedge System | Paragon 28 | 2017-04-03 | Traditional | PDF ↗ |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015-08-12 | Traditional | PDF ↗ |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | 2015-07-28 | Traditional | PDF ↗ |
Product code PLF · Class II · Orthopedic. Data: openFDA.