Clariance Inc
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 22
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1986-2019 | Class III | Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-L | July 1, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | January 14, 2025 |
| K243670 | Idys® LIF | December 31, 2024 |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | July 24, 2024 |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | April 26, 2024 |
| K240715 | Idys® C ZP 3DTi | March 22, 2024 |
| K220182 | Aggeris-C | March 30, 2022 |
| K212562 | Idys-C ZP 3DTi | October 12, 2021 |
| K200919 | Idys ALIF 3DTi | April 12, 2021 |
| K202032 | Idys LLIF 3DTi | April 1, 2021 |
| K202956 | Erisma LP Navigated Instruments | February 26, 2021 |
| K200920 | Idys ALIF ZP 3DTi | May 29, 2020 |
| K192168 | Idys ALIF ZP 3DTi | November 4, 2019 |
| K191263 | Idys ALIF TiVac | June 6, 2019 |
| K183259 | Idys TLIF TiVac | March 1, 2019 |
| K172465 | Idys TLIF 3DTi Cages | December 15, 2017 |
| K172083 | Idys ALIF System | November 8, 2017 |
| K170163 | Erisma® LP Spinal Fixation System | February 14, 2017 |
| K162367 | Erisma® LP MIS | October 27, 2016 |
| K153326 | Erisma-LP Spinal Fixation System | March 8, 2016 |
| K130853 | IDYS(TM) C | November 13, 2013 |