FDA Registration
Active
🇺🇸 United States
Clariance, Inc.
Reg #: 3009962553
·
FEI: 3009962553
·
Expires 2026
Products
22
Proprietary Names
29
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- Clariance, Inc.
- Registration Number
- 3009962553
- FEI Number
- 3009962553
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2547 Farrington St
- City
- Dallas
- State
- TX
- ZIP
- 75207
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183259
Owner / Operator
- Firm Name
- CLARIANCE-SAS
- Operator Number
- 10043711
- Address
- 18, rue Robespierre
- City
- BEAURAINS
- State
- Pas-de-Calais
- Postal Code
- 62217
- Country
- FR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-03-04 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-03-25 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2018-06-07 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-03-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-03-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-03-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-03-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-06-24 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2018-05-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-04-19 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-07-01 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-11-25 |
| Probe | HXB | Class 1 | Orthopedic | No | 2018-10-24 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-05-24 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-07-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2018-05-24 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2018-06-07 |
| Instrument, Cranioplasty Material Forming | HBX | Class 1 | Neurology | No | 2021-07-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-03-29 |
Proprietary Names
Idys TLIF TiVac
ERISMA® LP_NAVIGATED INSTRUMENTS
Idys-ALIF
Idys® C ZP 3DTi
Erisma-LP
Idys® LLIF 3DTi
Idys TLIF
Idys PTLIF
Idys PLIF
Idys® LIF
Idys ALIF TiVac
Aggeris-C
Idys-ALIF
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
RASP
IDYS-C© ZP 3DTi
Idys-C
spinal instruments
Elegance® Anterior Cervical Plate
Erisma® LP MIS
Erisma® Lp Spinal Fixation System
Bone Awl
Pedicular probe
Idys® ALIF ZP 3DTi
ERISMA LP MIS
Idys TLIF 3DTi
SPINAL INSTRUMENTS
Idys-LIF
Idys® ALIF 3DTi
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only