The following data is part of a premarket notification filed by Osteomed Llc with the FDA for Osteoplan System.
| Device ID | K212570 |
| 510k Number | K212570 |
| Device Name: | OsteoPlan System |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | OsteoMed LLC 3885 Arapaho Road Addison, TX 75001 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford OsteoMed LLC 3885 Arapaho Road Addison, TX 75001 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-02-11 |