Clariance, Inc.

FDA Device Registration & Listing · Dallas, TX, US · Registration 3009962553

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
3009962553
FEI Number
3009962553
Entity Name
Clariance, Inc.
City/State/Country
Dallas, TX, US
Establishment Address
2547 Farrington St, Dallas, TX 75207, US
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CLARIANCE-SAS (Owner Number: 10043711)
Owner / Operator Contact Address
18, rue Robespierre, BEAURAINS, FR-62 62217, FR
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Idys TLIF TiVac ERISMA® LP_NAVIGATED INSTRUMENTS Idys-ALIF Idys® C ZP 3DTi Erisma-LP Idys-ALIF Idys® LLIF 3DTi Erisma-LP Idys-ALIF 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 Idys-ALIF Bone Awl Idys-ALIF Erisma-LP Idys-ALIF Idys-ALIF Idys-ALIF Pedicular probe

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 2019-03-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-03-25
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-06-07
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-03-26
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 2020-06-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-06-24
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-05-24
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
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
HTX Rongeur Orthopedic Class 1 888.4540 2018-05-24
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 2025-01-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-07-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-04-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-06-24
HTR Rasp General, Plastic Surgery Class 1 878.4800 2021-07-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-11-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-11-25
HXB Probe Orthopedic Class 1 888.4540 2018-10-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-08-02
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-05-24
HWJ Awl Orthopedic Class 1 888.4540 2021-07-01
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-05-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-03-30
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-05-24
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-05-24
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2018-06-07
HBX Instrument, Cranioplasty Material Forming Neurology Class 1 882.4500 2021-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3008992889 CLARIANCE-SAS BEAURAINS Hauts-de-France, FR

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-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009962553. Last updated year: 2026. Please use registration number 3009962553 when referencing this establishment in official correspondence.
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