Clariance, Sas
Medical device manufacturer in Beaurains, Fran.
22510(k) clearances
0PMA approvals
2recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 6
- MAX Intervertebral Fusion Device With Bone… 6
- OVD Intervertebral Fusion Device With… 4
- OVE Intervertebral Fusion Device With… 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- ODP Intervertebral Fusion Device With Bone… 1
- OLO Orthopedic Stereotaxic Instrument 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | 01/14/2025SE |
| K243670 | Idys® LIFMAX · Special | 12/31/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | 07/24/2024SE |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special | 04/26/2024SE |
| K240715 | Idys® C ZP 3DTiOVE · Special | 03/22/2024SE |
| K220182 | Aggeris-CKWQ · Traditional | 03/30/2022SE |
| K212562 | Idys-C ZP 3DTiOVE · Traditional | 10/12/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | 04/12/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | 04/01/2021SE |
| K202956 | Erisma LP Navigated InstrumentsOLO · Traditional | 02/26/2021SE |
| K200920 | Idys ALIF ZP 3DTiMAX · Special | 05/29/2020SE |
| K192168 | Idys ALIF ZP 3DTiOVD · Traditional | 11/04/2019SE |
| K191263 | Idys ALIF TiVacOVD · Special | 06/06/2019SE |
| K183259 | Idys TLIF TiVacMAX · Traditional | 03/01/2019SE |
| K172465 | Idys TLIF 3DTi CagesMAX · Traditional | 12/15/2017SE |
| K172083 | Idys ALIF SystemOVD · Traditional | 11/08/2017SE |
| K170163 | Erisma® LP Spinal Fixation SystemNKB · Special | 02/14/2017SE |
| K162367 | Erisma® LP MISNKB · Traditional | 10/27/2016SE |
| K153326 | Erisma-LP Spinal Fixation SystemNKB · Special | 03/08/2016SE |
| K130853 | Idys(Tm) CODP · Traditional | 11/13/2013SE |
| K131178 | Idys Lif CagesMAX · Traditional | 10/10/2013SE |
| K120469 | Erisma-LpNKB · Traditional | 08/13/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1821-2026 Class II | Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL…Due to a quality issue regarding the presence of burr on the finished cervical plate product. | 02/20/2026Open, Classified |
| Z-1986-2019 Class III | Erisma- LP posterior fixation system with the below specifically affected products: 1.…Potential for the polyaxial screw to become disassembled during implant. | 07/01/2019Terminated |