INION OY

FDA Device Registration & Listing · TAMPERE Pirkanmaa, FI · Registration 9710629

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
9710629
FEI Number
3003407235
Entity Name
INION OY
City/State/Country
TAMPERE Pirkanmaa, FI
Establishment Address
LAAKARINKATU 2, TAMPERE Pirkanmaa 33520, FI
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Beijing Naton Technology Group Co. Ltd. (Owner Number: 10035021)
Owner / Operator Contact Address
No.9, Chengwan Street, Haidian District, Beijing, CN-BJ 100094, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Inion Spinal Graft Containment System Inion S-2 Accessory Instrument Inion Instrument Inion CPS Biodegradable Fixation System Inion Hexalon Biodegradable ACL/PCL Screw Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion FreedomPin Inion Instrumentation Inion BioRestore Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion OTPS Biodegradable Distal Radius Plate Inion Hexalon Accessory Instrument Inion Hexalon Biodegradable ACL/PCL Screw Inion BioRestore Synthetic Bone Graft Substitute Inion Instrument Inion OTPS Biodegradable Mini Screws Inion Instrumentation Inion S-1 Accessory Instrument Inion S-2 Accessory Instrument Inion Biodegradable Spinal Graft Containment System Inion Instrument Inion OTPS Biodegradable Mini Plating System Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion OTPS Pin Inion CompressOn Screw Inion CompressOn Screw accessory instruments Inion FreedomPlate Inion CPS Orbital Plates Inion CPS Instrument Inion Instrument Inion CPS Baby Biodegradable Fixation System Inion OTPS Mesh Biodegradable Plating System Inion Instrumentation Inion FreedomScrew Inion Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate Orthopedic Class 2 888.3060 2015-10-09
JEY Plate, Bone Dental Class 2 872.4760 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-27
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2011-01-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2011-01-27
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2011-02-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2014-04-24
HXJ Staple Driver Orthopedic Class 1 888.4540 2011-01-27
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-08-01
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2011-01-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2011-01-27
HXC Wrench Orthopedic Class 1 888.4540 2011-01-27
HWW Countersink Orthopedic Class 1 888.4540 2011-01-27
HWX Tap, Bone Orthopedic Class 1 888.4540 2011-01-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-27
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2011-01-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-27
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-27
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2011-01-27
OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate Orthopedic Class 2 888.3060 2011-01-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-27
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2011-01-27
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2011-01-27
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2011-01-27
HWJ Awl Orthopedic Class 1 888.4540 2011-01-27
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2015-10-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-01-27
JEY Plate, Bone Dental Class 2 872.4760 2013-03-04
JEY Plate, Bone Dental Class 2 872.4760 2011-01-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-01-27
HWT Template Orthopedic Class 1 888.4800 2011-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-03-04
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2013-05-17

Official Correspondent

No official correspondent registered.

US Agent Details

Rebecca Proulx Business: Inion, Inc. Email: rebecca.proulx@inion.com Phone: (954) 6599224

Related Public Records

Same Entity

Beijing Naton Technology Group Co. Ltd.
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
K172572 Stryker Stryker Upper-Face AXS screws and Mid-Face AXS screws 2017-10-31
K121589 Biomet Microfixation BIOMET MICROFIXATION FACIAL PLATING SYSTEM 2012-09-21
K984230 Osteogenics Biomedical, Inc. OSTEO-MESH TM-300 1999-02-04
K021618 Osteomed Corp. OSA RIGID INTERNAL FIXATION SYSTEM 2002-08-08
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2007 Bioplate Inc 2
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
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.

Similar Registrations

Registration Number Establishment Name Location
3002807310 Synergy Health Sterilisation UK Ltd Berkshire Reading, GB
3015780293 ARCTIC BIOMATERIALS OY Tampere Pirkanmaa, FI
9681465 Gammatom S.r.l. GUANZATE (CO) Como, IT
3017734069 REOSS GMBH Filderstadt Baden-Wurttemberg, DE
1032347 BIOMET MICROFIXATION Jacksonville, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710629. Last updated year: 2026. Please use registration number 9710629 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.