CLARIANCE-SAS

FDA Device Registration & Listing · BEAURAINS Hauts-de-France, FR · Registration 3008992889

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008992889
FEI Number
3008992889
Entity Name
CLARIANCE-SAS
City/State/Country
BEAURAINS Hauts-de-France, FR
Establishment Address
18, rue Robespierre, BEAURAINS Hauts-de-France 62217, FR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CLARIANCE-SAS (Owner Number: 10043711)
Owner / Operator Contact Address
18, rue Robespierre, BEAURAINS, FR-62 62217, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Idys® ALIF 3DTi Idys-ALIF ERISMA® LP_NAVIGATED INSTRUMENTS Idys® LLIF 3DTi Idys-ALIF Idys® ALIF ZP 3DTi Idys™ TLIF 3DTi SPINAL INSTRUMENTS Idys-ALIF Idys-LIF RASP Idys™-ALIF ERISMA LP MIS Idys-ALIF Idys-ALIF Erisma® LP MIS Erisma® Lp Spinal Fixation System Idys-ALIF Aggeris-C Idys-ALIF Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System Erisma-LP Pedicular probe Erisma-LP IDYS-C© ZP 3DTi PLUS PIVOT LINK UNIVERSAL SYSTEM Erisma-LP Idys TLIF Idys PTLIF Idys PLIF Idys TLIF TiVac Idys-ALIF Elegance® Anterior Cervical Plate Idys-ALIF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-07-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-07-02
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2018-06-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-03-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-04-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-04-02
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-05-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-12-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-03-29
HTR Rasp General, Plastic Surgery Class 1 878.4800 2021-07-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-11-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-11-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-11-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-05-24
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-06-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-08-02
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-05-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-04-19
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-05-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-24
HBX Instrument, Cranioplasty Material Forming Neurology Class 1 882.4500 2021-07-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-03-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-11-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-03-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-03-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-03-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-10-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-03-04
HTX Rongeur Orthopedic Class 1 888.4540 2018-05-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-21
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

Sylvain CHAMBAT Business: Clariance, Inc. Email: s.chambat@clariance-spine.us Phone: (773) 8327554

Related Public Records

Same Entity

CLARIANCE-SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009962553 Clariance, Inc. Dallas, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008992889. Last updated year: 2026. Please use registration number 3008992889 when referencing this establishment in official correspondence.
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