INION OY

Registration Details

Registration Name: INION OY
Registration Number: 9710629
FEI Number: 3003407235
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: LAAKARINKATU 2
City: TAMPERE Pirkanmaa
Country: FI

Regulatory Submissions

510(k) Number: K151360

Owner / Operator

Firm Name: Beijing Naton Technology Group Co. Ltd.
Operator Number: 10035021
Address: No.9, Chengwan Street, Haidian District
City: Beijing
State: CN-BJ
Postal Code: 100094
Country: CN

US Agent

Business Name: Inion, Inc.
Contact Name: Rebecca Proulx
Address: 37 North Orange Avenue, Suite 900C
City: Orlando
State: FL
ZIP: 32801
Country: US
Email: [email protected]
Phone: 954 6599224

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	OJB	Class 2	Orthopedic	No	2015-10-09
Plate, Bone	JEY	Class 2	Dental	No	2011-01-27
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2011-01-27
Starter, Bone Screw	HWD	Class 1	Orthopedic	No	2011-01-27
Bit, Drill	HTW	Class 1	Orthopedic	No	2011-01-27
Cutter, Surgical	FZT	Class 1	General, Plastic Surgery	No	2011-02-14
Pin, Fixation, Smooth	HTY	Class 2	Orthopedic	No	2014-04-24
Staple Driver	HXJ	Class 1	Orthopedic	No	2011-01-27
Filler, Bone Void, Calcium Compound	MQV	Class 2	Orthopedic	No	2019-08-01
Instrument, Bending Or Contouring	HXP	Class 1	Orthopedic	No	2011-01-27
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2011-01-27
Wrench	HXC	Class 1	Orthopedic	No	2011-01-27
Countersink	HWW	Class 1	Orthopedic	No	2011-01-27
Tap, Bone	HWX	Class 1	Orthopedic	No	2011-01-27
Plate, Fixation, Bone	HRS	Class 2	Orthopedic	No	2011-01-27
Staple, Fixation, Bone	JDR	Class 2	Orthopedic	No	2011-01-27
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	Class 2	Orthopedic	No	2011-01-27
Pliers, Surgical	HTC	Class 1	General, Plastic Surgery	No	2011-01-27
Tray, Surgical	LRP	Class 1	General, Plastic Surgery	No	2011-01-27
Gauge, Depth	HTJ	Class 1	Orthopedic	No	2011-01-27
Accessories, Retractor, Dental	EIF	Class 1	Dental	No	2011-01-27
Awl	HWJ	Class 1	Orthopedic	No	2011-01-27
Template	HWT	Class 1	Orthopedic	No	2011-01-27
Orthopedic Tray	OJH	Class 1	General, Plastic Surgery	No	2013-05-17
Barrier, Synthetic, Intraoral	NPK	Class 2	Dental	No	2011-01-27
Unit, Heating, Powered	IRQ	Class 1	Physical Medicine	No	2011-01-27
Bone Grafting Material, Synthetic	LYC	Class 2	Dental	No	2011-01-27
Guide, Surgical, Instrument	FZX	Class 1	General, Plastic Surgery	No	2011-01-27
Screwdriver	HXX	Class 1	Orthopedic	No	2011-01-27
Accessories, Arthroscopic	NBH	Class 1	Orthopedic	No	2011-01-27

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 FreedomPin Inion BioRestore Inion OTPS Biodegradable Distal Radius Plate Inion Hexalon Accessory Instrument Inion BioRestore Synthetic Bone Graft Substitute Inion OTPS Biodegradable Mini Screws Inion S-1 Accessory Instrument Inion Biodegradable Spinal Graft Containment System Inion OTPS Biodegradable Mini Plating System Inion OTPS Pin Inion CompressOn Screw Inion CompressOn Screw accessory instruments Inion FreedomPlate Inion CPS Orbital Plates Inion CPS Instrument Inion CPS Baby Biodegradable Fixation System Inion OTPS Mesh Biodegradable Plating System Inion FreedomScrew Inion Instruments Inion S-1 accessory instruments Inion S-1 Anterior Cervical Fusion System for Graft Containm Inion OTPS Biodegradable Pin Inion GTR Accessory Instrument Inion GTR Biodegradable Membrane System Inion CPS Biodegradable BSSO Screw Inion Thermo+ Waterbath Inion Thermo Waterbath Inion OTPS Biodegradable Fixation System

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)