MedCAD® AccuPlan® System
FDA 510(k) K192282 · Medcad
510(k) numberK192282
Submission
- Device name
- MedCAD® AccuPlan® System
- Applicant
- Medcad
Dallas, TX, US - Received
- August 22, 2019
- Decision date
- October 29, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | Materialise NV | 02/21/2025SE |
| K242263 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery, Inc. | 12/11/2024SE |
| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252064 | MedCAD® AccuStride SystemPBF · Traditional | 03/27/2026SE |
| K251709 | MedCAD® AccuStride SystemPBF · Traditional | 11/04/2025SE |
| K241811 | MedCAD® AccuStride SystemPBF · Traditional | 03/13/2025SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | 09/26/2023SE |
| K223421 | MedCAD AccuPlan Orthopedics SystemPBF · Traditional | 09/20/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | 03/07/2023SE |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | 08/26/2022SE |
| K193280 | MedCAD® AccuPlate® Patient-Specific PlateJEY · Traditional | 02/12/2021SE |
Questions and answers
When was MedCAD® AccuPlan® System cleared by the FDA?
MedCAD® AccuPlan® System (K192282) received a 510(k) decision of Substantially Equivalent on October 29, 2020, 434 days after the submission was received.
What is the product code of K192282?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.