COULOT DECOLLETAGE

FDA Device Registration & Listing · CHATELLERAULT Vienne, FR · Registration 3006217744

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
3006217744
FEI Number
3006217744
Entity Name
COULOT DECOLLETAGE
City/State/Country
CHATELLERAULT Vienne, FR
Establishment Address
1, RUE NUNGESSER ET COLI, CHATELLERAULT Vienne 86100, FR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
COULOT DECOLLETAGE SAS (Owner Number: 9093440)
Owner / Operator Contact Address
89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ASTRA-OCT Spine System PERLA Novastep Airlock SAMARYS PCB Evolution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-09-19
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-09-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-11-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-01-06
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-01-08
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2016-01-11
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-05-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-05-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-04-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-04-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-04-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-04-28
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-04-28
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2013-01-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-07-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-01-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-06-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-06-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-06-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-06-25
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-06-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-02-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-02-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-01-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-06-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-06-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-08-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2020-08-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-08-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2020-08-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-07-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-07-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-07-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-01-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-01-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-11-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2022-11-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-16
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2014-03-14
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2022-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-05
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2019-01-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-08
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2022-02-08
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-04-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-01-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-11-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-03-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-06-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-06-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-06-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-06-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-06-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-03-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-03-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-03-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-03-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-03-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-08
HWT Template Orthopedic Class 1 888.4800 2015-01-08
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2016-04-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-26
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-26
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2017-01-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-04-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-04-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-04-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-04-22

Official Correspondent

Lisa Boyle

US Agent Details

Tania Shammo Business: COULOT DECOLLETAGE Email: tshammo@exalta.com Phone: (262) 2886450

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006217744. Last updated year: 2026. Please use registration number 3006217744 when referencing this establishment in official correspondence.
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