Aegis Spine, Inc.
Aegis Spine, Inc. has 0 FDA recalls, 5 inspections, 6 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 18, 2017 · NAI
- Latest 510(k)
- Jan 20, 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 | 6 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 18, 2017 | Costa Mesa, CA | Devices | No Action Indicated (NAI) | 3009790163 |
| May 9, 2017 | Costa Mesa, CA | Biologics | No Action Indicated (NAI) | 3009790163 |
| Mar 19, 2014 | Costa Mesa, CA | Devices | Voluntary Action Indicated (VAI) | 3009790163 |
| Aug 30, 2013 | Costa Mesa, CA | Biologics | Voluntary Action Indicated (VAI) | 3009790163 |
| May 24, 2011 | Walnut, CA | Devices | No Action Indicated (NAI) | 3008111283 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223521 | ZESPIN SI Joint Fusion System | Jan 20, 2023 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Jan 11, 2023 |
| K221719 | ABTross ALIF Expandable Cage System | Nov 3, 2022 |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical… | Jun 30, 2022 |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior… | Feb 16, 2021 |
| K203531 | XYPAN Expandable Lumbar Cage System | Jan 29, 2021 |