Osseus Fusion Systems
Osseus Fusion Systems has 0 FDA recalls, 2 inspections, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 24, 2018 · NAI
- Latest 510(k)
- Feb 10, 2023
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 10 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 24, 2018 | Dallas, TX | Devices | No Action Indicated (NAI) | 3010531060 |
| Apr 23, 2015 | Dallas, TX | Devices | Voluntary Action Indicated (VAI) | 3010531060 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223413 | Pisces-SA STANDALONE ALIF Interbody System | Feb 10, 2023 |
| K222107 | Black Diamond POCT Spinal System | Nov 3, 2022 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | May 6, 2022 |
| K213590 | Blue Topaz Sacroiliac Screw System | Mar 1, 2022 |
| K192495 | Black Diamond Navigation Instruments | Jan 17, 2020 |
| K192121 | Black Diamond Pedicle Screw System | Oct 29, 2019 |
| K181347 | Aries® Lumbar Interbodies | Aug 15, 2018 |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Jul 3, 2017 |
| K160522 | White Pearl Preferred Angle Anterior Cervical Plate | Apr 26, 2016 |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | Aug 8, 2013 |