Osteocentric Trauma
Osteocentric Trauma has 0 FDA recalls, 2 inspections, 14 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 13, 2023 · VAI
- Latest 510(k)
- Oct 27, 2025
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 14 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 13, 2023 | Logan, UT | Devices | Voluntary Action Indicated (VAI) | 3011656326 |
| Aug 30, 2016 | Logan, UT | Devices | No Action Indicated (NAI) | 3011656326 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments System | Oct 27, 2025 |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | Aug 16, 2025 |
| K250494 | The OsteoCentric Bone Plate and Screw System | Mar 18, 2025 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | Oct 9, 2024 |
| K230242 | OsteoCentric Dental Implant System | Oct 5, 2023 |
| K230226 | Integrity-SI® Fusion System | Sep 21, 2023 |
| K230595 | OsteoCentric ACL Fixation System | Jun 29, 2023 |
| K230764 | OsteoCentric Integrated Hip Fastener System | Apr 18, 2023 |
| K222512 | Integrity-SI Fusion System | Sep 12, 2022 |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | Jul 28, 2022 |
| K211290 | Cannulated Fasteners and Nuts | Aug 3, 2021 |
| K210247 | OsteoCentric Integrated Hip Fastener System | Apr 30, 2021 |
| K210754 | Cannulated Fasteners and Nuts | Apr 14, 2021 |
| K190430 | OsteoCentric Bone Plate and Screw System | Mar 22, 2019 |