510(k) K103136
- Device
- SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
- Applicant
- MATERIALISE N.V.
- 510(k) number
- K103136
- Product code
- JEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-18
- Date received
- 2010-10-25
- Regulation
- 872.4760
- Classification name
- Plate, Bone
- Medical specialty
- Dental
- Review panel
- Dental
- Clearance type
- Traditional
- Third party reviewed
- No
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|---|---|---|---|
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026-07-25 |
| K252246 | Leforte MMF System | Jeil Medical Corporation | 2026-04-02 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | 2025-11-07 |
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| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 |
| K233874 | tmCMF Solution | Techmah Cmf | 2024-07-11 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024-04-30 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024-01-13 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023-09-26 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 |
Legacy Summary#
summary
FDA Review#
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