FDA Registration
Active
🇫🇷 France
CLARIANCE-SAS
Reg #: 3008992889
·
FEI: 3008992889
·
Expires 2026
Products
22
Proprietary Names
29
Establishment Types
4
Classifications
22
Registration Details
- Registration Name
- CLARIANCE-SAS
- Registration Number
- 3008992889
- FEI Number
- 3008992889
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18, rue Robespierre
- City
- BEAURAINS Hauts-de-France
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K200919
Owner / Operator
- Firm Name
- CLARIANCE-SAS
- Operator Number
- 10043711
- Address
- 18, rue Robespierre
- City
- BEAURAINS
- State
- Pas-de-Calais
- Postal Code
- 62217
- Country
- FR
US Agent
- Business Name
- Clariance, Inc.
- Contact Name
- Sylvain CHAMBAT
- Address
- 2547 Farrington St
- City
- Dallas
- State
- TX
- ZIP
- 75207
- Country
- US
- [email protected]
- Phone
- 773 8327554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-07-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-07-02 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2018-06-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-03-25 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-03-29 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-07-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-11-15 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-15 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2018-06-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-05-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-04-19 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Instrument, Cranioplasty Material Forming | HBX | Class 1 | Neurology | No | 2021-07-01 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-11-02 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-02-20 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2018-05-24 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-07-01 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-11-25 |
Proprietary Names
Idys® ALIF 3DTi
Idys-ALIF
ERISMA® LP_NAVIGATED INSTRUMENTS
Idys® LLIF 3DTi
Idys® ALIF ZP 3DTi
Idys TLIF 3DTi
SPINAL INSTRUMENTS
Idys-LIF
RASP
Idys-ALIF
ERISMA LP MIS
Erisma® LP MIS
Erisma® Lp Spinal Fixation System
Aggeris-C
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
Erisma-LP
Pedicular probe
IDYS-C© ZP 3DTi
PLUS PIVOT LINK UNIVERSAL SYSTEM
Idys TLIF
Idys PTLIF
Idys PLIF
Idys TLIF TiVac
Elegance® Anterior Cervical Plate
Bone Awl
Idys® LIF
Idys ALIF TiVac
Idys-C
Idys® C ZP 3DTi
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)