FDA Product Code
FDA Product Code PBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252064 | MedCAD® AccuStride System | Medcad | 2026-03-27 | Traditional | PDF ↗ |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 | Traditional | PDF ↗ |
| K242603 | MyPAO SA guides | Medacta International S.A. | 2025-11-19 | Traditional | PDF ↗ |
| K251709 | MedCAD® AccuStride System | Medcad | 2025-11-04 | Traditional | PDF ↗ |
| K250394 | Fine TTO | Bodycad Laboratories, Inc. | 2025-10-21 | Traditional | PDF ↗ |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 | Traditional | PDF ↗ |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K241811 | MedCAD® AccuStride System | Medcad | 2025-03-13 | Traditional | PDF ↗ |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-02-13 | Traditional | PDF ↗ |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024-11-07 | Traditional | PDF ↗ |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024-03-18 | Traditional | PDF ↗ |
| K240066 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2024-02-09 | Special | PDF ↗ |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023-10-25 | Traditional | PDF ↗ |
| K223421 | MedCAD AccuPlan Orthopedics System | Medcad | 2023-09-20 | Traditional | PDF ↗ |
| K231314 | Fine Osteotomy | Bodycad Laboratories, Inc. | 2023-06-02 | Special | PDF ↗ |
| K220706 | MyPAO Guides | Medacta International S.A. | 2023-05-30 | Traditional | PDF ↗ |
| K221943 | EmbedMed | 3D Lifeprints UK , Ltd. | 2023-02-01 | Traditional | PDF ↗ |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2022-08-04 | Traditional | PDF ↗ |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | 2022-06-28 | Traditional | PDF ↗ |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022-06-09 | Traditional | PDF ↗ |
| K212237 | 3D-Cut | 3D-Side S.A. | 2021-11-29 | Traditional | PDF ↗ |
| K211244 | VSP® Orthopedics System | 3D Systems | 2021-11-10 | Traditional | PDF ↗ |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020-03-11 | Traditional | PDF ↗ |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019-08-21 | Traditional | PDF ↗ |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017-01-18 | Traditional | PDF ↗ |
| K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | Materialise NV | 2014-04-10 | Traditional | PDF ↗ |
| K112389 | SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | 2012-07-20 | Traditional | PDF ↗ |
Product code PBF · Class II · Orthopedic. Data: openFDA.