NEWCLIP TECHNICS SAS

FDA Device Registration & Listing · HAUTE GOULAINE Loire-Atlantique, FR · Registration 3007143290

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
3007143290
FEI Number
3007143290
Entity Name
NEWCLIP TECHNICS SAS
City/State/Country
HAUTE GOULAINE Loire-Atlantique, FR
Establishment Address
PA DE LA LANDE SAINT MARTIN, HAUTE GOULAINE Loire-Atlantique 44115, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NEWCLIP TECHNICS SAS (Owner Number: 9089479)
Owner / Operator Contact Address
PA DE LA LANDE SAINT MARTIN, 45 rue des Garottieres, HAUTE GOULAINE, FR-PDL 44115, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Xpert Wrist INSTRUMENT, COMPRESSION Humerus Locking Plating System Activmotion Range Activmotion S Alians Fragment Specific screwdriver Clavicle Plate screwdriver ACTIV Ankle screwdriver Alians screwdriver Distal Radius Plate screwdriver Elbow screwdriver Large screw screwdriver T20 screwdriver ACTIV Ankle Removal kit Footmotion screwdriver Newclip Radius screwdriver Distal Radius removal kit Newclip Shoulder screwdriver Foot & Hand Motion screwdriver Clavicle prehensor screwdriver countersink HTO hexagonal screwdriver Xpert PFP screwdriver Footmotion bending plier ACTIV Ankle forceps Alians Bending iron Foot and Motion bending plier Alians Fragment Specific Bending plier Elbow reduction forceps ACTIV Ankle bending iron Elbow Vebrugge forceps Alians Clavicle Bending plier Elbow bending iron Distal Radius reduction forceps Xpert PFP bending iron Foot and Hand Motion Range Footmotion Plating System Activ Ankle Patient Specific Instruments Large Screw System Alians Elbow Plating System FTP Footmotion Plating System Alians Fragment Specific Screw length gauge Elbow length gauge for screws Large Screw length gauge Footmotion length gauge HTO Screw Length gauge Newclip Radius length gauge for screws Clavicle Plate screw length gauge Foot & Hand Motion length gauge ACTIV Ankle length gauge Alians Length gauge Activ Ankle length gauge for screws Newclip Shoulder length gauge for screws Distal Radius length gauge Xpert PFP length gauge Newclip Patient-matched instrumentation non sterile PSI Alians Clavicle range Foot & Hand Motion staple impactor IMPACTOR Xpert PFP impactor KNIFE, SURGICAL Large Screw System Xpert PFP instrumentation set Activ instrumentation set - Base HammerToe instrumentation set - Cover Clavicle instrumentation set HammerToe instrumentation set Stainless steel - Cover ACTIV Ankle instrumentation set HammerToe instrumentation set - Base ACTIV HTO instrumentation set Large screw instrumentation set Alians Fragment Specific instrumentation set Radius instrumentation set Humerus instrumentation set Footmotion instrumentation set Activ instrumentation set - Screws tray HammerToe instrumentation set Stainless steel - Base Foot and Hand Motion instrumentation set Distal instrumentation set Elbow instrumentation set Activ instrumentation set - Top Alians Elbow Distal Humerus Y Plates instrumentation set Ulnar Instrumentation set Footmotion Plating System MTP instrumentation set DTO S Distal Radius Plating System Xpert PFP drill bit BIT, DRILL Alians Ulnar Shortening System HTO cutting guide HTO Chisel Pauwels Metallic wedge for knee osteotomy Activ NCT Cutting guide Foot & Hand Motion chevron cutting guide Alians block for ulna plate Alians cutting guide PSI cutting guide TAPE, MEASURING, RULERS AND CALIPERS Newclip Patient-matched instrumentation non sterile PSI Handle for wedges and osteotomy cutting guide Large screw QC handle HANDLE, SCALPEL Large screw single use handle Large screw QC adaptor Large screw extension stem Xpert PFP QC handle Alians Fragment Specific HTO Meary pliers Clavicle Plate forceps Large screw prehensive plier Foot & Hand Motion forceps Alians forceps Foot & Hand Motion prehensive pliers for screws HammerToe Holder for interphalangeal implant Verbrugge forceps ACTIV Ankle washer pin ACTIV Ankle Prehensive plier TEMPLATE Newclip Patient-matched instrumentation non sterile PSI Activ Ankle Locking Plate System Clavicle Plating System Newclip Radius Plates CRIMPER, PIN Xpert PFP drill guide Xpert PFP guide gauge Foot and Hand Motion length gauge DTS Trauma drill guide Alians drill guide for Ulna Guide, Surgical, Instrument Distal Radius fast drilling guide Elbow drill guide HTO drill guide for DTS screws Footmotion osteotomy instrument Clavicle Plate drilling guide Activ drill guide QC system Activ Spacer for HTO - ACL Large screw protection sleeve Footmotion guide gauge Clavicle Plate guide gauge Newclip Shoulder Drill Guides ACTIV Ankle guide gauge Radius guide gauge Elbow guide gauge HTO alignment guide Large Screw length gauge for pin Large screw guide Foot & Hand Motion Pin guide Soft tissue protector Distal Radius guide gauge Humerus drill guide Activ pin guide Alians Fragment Specific drill guide Newclip Radius drilling guide Large screw pin guide ACTIV Ankle drilling guide for plates Alians guide gauge Support for HTO alignment guide Newclip Radius drill guide for screws

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-06
HWN Instrument, Compression Orthopedic Class 1 888.4540 2013-01-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-11-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-11-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-03-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-05
HXX Screwdriver Orthopedic Class 1 888.4540 2010-12-03
HTD Forceps General, Plastic Surgery Class 1 878.4800 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-22
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-02-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-10-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-04-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-04-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-09-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-09-14
HWW Countersink Orthopedic Class 1 888.4540 2026-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-12-13
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2010-12-03
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2026-01-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-08-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-08-07
HWA Impactor Orthopedic Class 1 888.4540 2011-01-27
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2023-03-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-09-26
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2011-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-30
HTW Bit, Drill Orthopedic Class 1 888.4540 2010-12-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-06-02
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2013-01-14
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2013-12-27
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2024-11-26
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2011-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-13
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2011-01-27
HWT Template Orthopedic Class 1 888.4800 2013-01-14
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2023-11-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-05-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-05-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-12-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-12-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2006-09-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2006-09-27
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2011-01-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2011-01-24

Official Correspondent

No official correspondent registered.

US Agent Details

J.D. Webb Business: THE ORTHOMEDIX GROUP, INC. Email: jdwebb@orthomedix.net Phone: (512) 5905810

Related Public Records

Same Entity

NEWCLIP TECHNICS 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 3007143290. Last updated year: 2026. Please use registration number 3007143290 when referencing this establishment in official correspondence.
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