OsteoCentric Technologies
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250520 | OsteoCentric Navigated Instruments System | October 27, 2025 |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | August 16, 2025 |
| K250494 | The OsteoCentric Bone Plate and Screw System | March 18, 2025 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | October 9, 2024 |
| K230242 | OsteoCentric Dental Implant System | October 5, 2023 |
| K230226 | Integrity-SI® Fusion System | September 21, 2023 |
| K230595 | OsteoCentric ACL Fixation System | June 29, 2023 |
| K230764 | OsteoCentric Integrated Hip Fastener System | April 18, 2023 |
| K222512 | Integrity-SI Fusion System | September 12, 2022 |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | July 28, 2022 |
| K211290 | Cannulated Fasteners and Nuts | August 3, 2021 |
| K210754 | Cannulated Fasteners and Nuts | April 14, 2021 |