OsteoPlan System
FDA 510(k) K212570 · Osteomed, LLC
510(k) numberK212570
Submission
- Device name
- OsteoPlan System
- Applicant
- Osteomed, LLC
Addison, TX, US - Received
- August 16, 2021
- Decision date
- February 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
| K193301 | coDiagnostiXDZJ · Traditional | Dental Wings GmbH | 06/21/2021SE |
More from Dental Wings GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K203479 | ExtremiLOCK Lateral Ankle Fusion PlatesHRS · Traditional | 02/24/2021SE |
| K202105 | OsteoMed ExtremiFix Mini & Small System TrayKCT · Traditional | 10/29/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
| K151195 | OsteoMed IMF ScrewDZL · Traditional | 09/21/2015SE |
Questions and answers
When was OsteoPlan System cleared by the FDA?
OsteoPlan System (K212570) received a 510(k) decision of Substantially Equivalent on February 11, 2022, 179 days after the submission was received.
What is the product code of K212570?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.