Clariance Inc
FDA Regulatory Profile
Clariance Inc appears in FDA public data with 2 recalls, 22 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1821-2026, Class II) was initiated on Feb 20, 2026. Its most recent 510(k) clearance was granted on Jan 14, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 22
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1821-2026 | Class II | Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGAN | Feb 20, 2026 |
| Z-1986-2019 | Class III | Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-L | Jul 1, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243904 | Elegance® Anterior Cervical plate | Jan 14, 2025 |
| K243670 | Idys® LIF | Dec 31, 2024 |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Jul 24, 2024 |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Apr 26, 2024 |
| K240715 | Idys® C ZP 3DTi | Mar 22, 2024 |
| K220182 | Aggeris-C | Mar 30, 2022 |
| K212562 | Idys-C ZP 3DTi | Oct 12, 2021 |
| K200919 | Idys ALIF 3DTi | Apr 12, 2021 |
| K202032 | Idys LLIF 3DTi | Apr 1, 2021 |
| K202956 | Erisma LP Navigated Instruments | Feb 26, 2021 |
| K200920 | Idys ALIF ZP 3DTi | May 29, 2020 |
| K192168 | Idys ALIF ZP 3DTi | Nov 4, 2019 |
| K191263 | Idys ALIF TiVac | Jun 6, 2019 |
| K183259 | Idys TLIF TiVac | Mar 1, 2019 |
| K172465 | Idys TLIF 3DTi Cages | Dec 15, 2017 |
| K172083 | Idys ALIF System | Nov 8, 2017 |
| K170163 | Erisma® LP Spinal Fixation System | Feb 14, 2017 |
| K162367 | Erisma® LP MIS | Oct 27, 2016 |
| K153326 | Erisma-LP Spinal Fixation System | Mar 8, 2016 |
| K130853 | IDYS(TM) C | Nov 13, 2013 |