510(k) K924138
- Device
- OSTEOMED M3 SYSTEM (SBF SYSTEM)
- Applicant
- OSTEOMED CORP.
- 510(k) number
- K924138
- Product code
- JEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-17
- Date received
- 1992-08-18
- Regulation
- 872.4760
- Classification name
- Plate, Bone
- Medical specialty
- Dental
- Review panel
- Dental
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code JEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2026-08-17 |
| 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 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases