Inion Oy

FDA Filings

This page includes the latest FDA filings for Inion Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003547707
• FEI Number: 3003547707
• Name: INION, INC.
• Owner & Operator: INION OY
• Contact Address: LAAKARINKATU 2 --; TAMPERE FI-LS Lansi-Suomen laani 33520 FI
• Official Correspondent:
  • KATI - MARTTINEN
  • 358-10-8306600-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2800 Glades Cir Ste 138 ; WESTON, FL 33327 US

• Registration Number: 9710629
• FEI Number: 3003407235
• Name: INION OY
• Owner & Operator: Beijing Naton Technology Group Co. Ltd.
• Contact Address: 03222, 03223 and 03224, 2nd floor, build No. 68 Yard Beiqing Road, Haidian Distri; Beijing CN-11 Beijing 100094 CN
• US Agent:
  • Allison Mercer
  • Inion, Inc.
  • 954 6599224
  • 954 6597997
  • allison.mercer@inion.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: LAAKARINKATU 2 ; TAMPERE Lansi-Suomen laani, 33520 FI
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID M224INS90979 Inion Oy	Inion instrument INS-9097	2025-06-02
GUDID M224INS909710 Inion Oy	Inion instrument INS-9097	2025-06-02
GUDID M224INS90719 Inion Oy	Inion instrument INS-9071	2025-06-02
GUDID M224INS907110 Inion Oy	Inion instrument INS-9071	2025-06-02
GUDID M224INS90379 Inion Oy	Inion instrument INS-9037	2025-06-02
GUDID M224INS90369 Inion Oy	Inion instrument INS-9036	2025-06-02
GUDID M224INS90359 Inion Oy	Inion instrument INS-9035	2025-06-02
GUDID M224INS90289 Inion Oy	Inion instrument INS-9028	2025-06-02
GUDID M224INS902810 Inion Oy	Inion instrument INS-9028	2025-06-02
GUDID M224INS90139 Inion Oy	Inion instrument INS-9013	2025-06-02
GUDID M224INS901310 Inion Oy	Inion instrument INS-9013	2025-06-02
GUDID M224INS90059 Inion Oy	Inion instrument INS-9005	2025-06-02
GUDID M224INS900510 Inion Oy	Inion instrument INS-9005	2025-06-02
GUDID M224INS958110 Inion Oy	Inion S-2 instrument INS-9581	2025-02-03
GUDID M224INS903710 Inion Oy	Inion instrument INS-9037	2025-02-03
GUDID M224INS903610 Inion Oy	Inion instrument INS-9036	2025-02-03
GUDID M224INS903510 Inion Oy	Inion instrument INS-9035	2025-02-03
GUDID 06438408009198 Inion Oy	Inion BioRestore™ BRS-5433	2025-02-03
GUDID 06438408009181 Inion Oy	Inion BioRestore™ BRS-5447	2025-02-03
GUDID 06438408009174 Inion Oy	Inion BioRestore™ BRS-5446	2025-02-03
GUDID 06438408009167 Inion Oy	Inion BioRestore™ BRS-5437	2025-02-03
GUDID 06438408009150 Inion Oy	Inion BioRestore™ BRS-5436	2025-02-03
GUDID 06438408009143 Inion Oy	Inion BioRestore™ BRS-5434	2025-02-03
GUDID 06438408009136 Inion Oy	Inion BioRestore™ BRS-5445	2025-02-03
GUDID 06438408009129 Inion Oy	Inion BioRestore™ BRS-5444	2025-02-03
GUDID 06438408009112 Inion Oy	Inion BioRestore™ BRS-5428	2025-02-03
GUDID 06438408009105 Inion Oy	Inion BioRestore™ BRS-5427	2025-02-03
GUDID 06438408007972 Inion Oy	Inion BioRestore™ BRS-5435	2025-02-03
GUDID 06438408007958 Inion Oy	Inion BioRestore™ BRS-5432	2025-02-03
GUDID M224ACC982310 Inion Oy	Inion S-1 instrument ACC-9823	2025-01-16
GUDID 06438408012419 Inion Oy	2.0 mm Inion OTPS™ PIN-5002	2024-04-10
GUDID 06438408012402 Inion Oy	2.0 mm Inion OTPS™ PCK-7002	2024-04-10
GUDID 06438408012389 Inion Oy	Inion FreedomPin™ OPK-20K3	2024-04-10
GUDID 06438408012372 Inion Oy	Inion FreedomPin™ OPK-20K2	2024-04-10
GUDID 06438408012365 Inion Oy	Inion FreedomPin™ OPK-20K1	2024-04-10
GUDID 06438408012358 Inion Oy	Inion FreedomPin™ OPK-15K3	2024-04-10
GUDID 06438408012341 Inion Oy	Inion FreedomPin™ OPK-15K2	2024-04-10
GUDID 06438408012334 Inion Oy	Inion FreedomPin™ OPK-15K1	2024-04-10
GUDID 06438408012327 Inion Oy	Inion S-2™ SPN-5417	2023-12-27
GUDID 06438408012310 Inion Oy	Inion S-2™ SPN-5416	2023-12-27
GUDID 06438408012303 Inion Oy	Inion S-1™ SPN-5212	2023-12-27
GUDID 06438408012297 Inion Oy	Inion S-1™ SPN-5211	2023-12-27
GUDID 06438408012280 Inion Oy	Inion S-1™ SPN-5210	2023-12-27
GUDID 06438408012273 Inion Oy	Inion S-1™ SPN-5205	2023-12-27
GUDID 06438408012266 Inion Oy	Inion S-1™ SPN-5204	2023-12-27
GUDID 06438408012259 Inion Oy	Inion S-1™ SPN-5203	2023-12-27
GUDID 06438408012242 Inion Oy	Inion S-1™ SPN-5202	2023-12-27
GUDID 06438408012235 Inion Oy	Inion S-1™ SPN-5201	2023-12-27
GUDID 06438408012228 Inion Oy	Inion S-1™ SPN-5200	2023-12-27
GUDID 06438408012211 Inion Oy	Inion S-1™ SPN-5007	2023-12-27
GUDID 06438408012204 Inion Oy	Inion S-1™ SPN-5006	2023-12-27
GUDID 06438408012198 Inion Oy	Inion S-1™ SPN-5005	2023-12-27
GUDID 06438408012181 Inion Oy	Inion S-1™ SPN-5004	2023-12-27
GUDID 06438408012174 Inion Oy	Inion S-1™ SPN-5003	2023-12-27
GUDID 06438408012167 Inion Oy	Inion S-1™ SPN-5002	2023-12-27
GUDID 06438408012150 Inion Oy	Inion S-1™ SPN-5001	2023-12-27
GUDID 06438408012143 Inion Oy	Inion S-1™ SPN-5000	2023-12-27
GUDID 06438408010750 Inion Oy	Inion GTR™ MBR-2000	2023-12-27
GUDID 06438408007279 Inion Oy	Inion GTR™ TCK-2002	2023-12-27
GUDID 06438408007163 Inion Oy	Inion S-2™ SPN-5507	2023-12-27
GUDID 06438408007156 Inion Oy	Inion S-2™ SPN-5506	2023-12-27
GUDID 06438408007033 Inion Oy	Inion S-2™ SPN-5409	2023-12-27
GUDID 06438408007026 Inion Oy	Inion S-2™ SPN-5408	2023-12-27
GUDID 06438408007019 Inion Oy	Inion S-2™ SPN-5407	2023-12-27
GUDID 06438408006883 Inion Oy	Inion S-1™ SPN-5021	2023-12-27
GUDID 06438408006876 Inion Oy	Inion S-1™ SPN-5020	2023-12-27
GUDID 06438408006791 Inion Oy	Inion S-1™ SPN-5012	2023-12-27
GUDID 06438408006784 Inion Oy	Inion S-1™ SPN-5011	2023-12-27
GUDID 06438408006777 Inion Oy	Inion S-1™ SPN-5010	2023-12-27
GUDID 06438408005572 Inion Oy	Inion GTR™ TCK-2013	2023-12-27
GUDID 06438408005565 Inion Oy	Inion GTR™ TCK-2011	2023-12-27
GUDID M224SPN55049 Inion Oy	Inion S-2™ SPN-5504	2023-12-19
GUDID M224SPN55039 Inion Oy	Inion S-2™ SPN-5503	2023-12-19
GUDID M224SPN55029 Inion Oy	Inion S-2™ SPN-5502	2023-12-19
GUDID M224SPN55019 Inion Oy	Inion S-2™ SPN-5501	2023-12-19
GUDID M224SPN55009 Inion Oy	Inion S-2™ SPN-5500	2023-12-19
GUDID M224SPN54249 Inion Oy	Inion S-2™ SPN-5424	2023-12-19
GUDID M224SPN54239 Inion Oy	Inion S-2™ SPN-5423	2023-12-19
GUDID M224SPN54229 Inion Oy	Inion S-2™ SPN-5422	2023-12-19
GUDID M224SPN54219 Inion Oy	Inion S-2™ SPN-5421	2023-12-19
GUDID M224SPN54109 Inion Oy	Inion S-2™ SPN-5410	2023-12-19
GUDID M224SPN54069 Inion Oy	Inion S-2™ SPN-5406	2023-12-19
GUDID M224SPN54059 Inion Oy	Inion S-2™ SPN-5405	2023-12-19
GUDID M224SPN54049 Inion Oy	Inion S-2™ SPN-5404	2023-12-19
GUDID M224SPN54039 Inion Oy	Inion S-2™ SPN-5403	2023-12-19
GUDID M224SPN54029 Inion Oy	Inion S-2™ SPN-5402	2023-12-19
GUDID M224SPN54019 Inion Oy	Inion S-2™ SPN-5401	2023-12-19
GUDID M224SPN52259 Inion Oy	Inion S-1™ SPN-5225	2023-12-19
GUDID M224SPN52249 Inion Oy	Inion S-1™ SPN-5224	2023-12-19
GUDID M224SPN52239 Inion Oy	Inion S-1™ SPN-5223	2023-12-19
GUDID M224SPN52229 Inion Oy	Inion S-1™ SPN-5222	2023-12-19
GUDID M224SPN52219 Inion Oy	Inion S-1™ SPN-5221	2023-12-19
GUDID M224SPN52209 Inion Oy	Inion S-1™ SPN-5220	2023-12-19
GUDID M224SPN50199 Inion Oy	Inion S-1™ SPN-5019	2023-12-19
GUDID M224SPN50189 Inion Oy	Inion S-1™ SPN-5018	2023-12-19
GUDID M224SPN50179 Inion Oy	Inion S-1™ SPN-5017	2023-12-19
GUDID M224SPN50169 Inion Oy	Inion S-1™ SPN-5016	2023-12-19
GUDID M224SPN50159 Inion Oy	Inion S-1™ SPN-5015	2023-12-19
GUDID M224SPN50149 Inion Oy	Inion S-1™ SPN-5014	2023-12-19
GUDID M224SPN50139 Inion Oy	Inion S-1™ SPN-5013	2023-12-19
PMN K203105 Inion Oy	Inion CompressOn Screw	2021-01-13
PMN K191764 | MQV INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion BioRestore	2019-08-01
PMN K191764 Inion Oy	Inion BioRestore	2019-07-31
HXO INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Shoulder Instrument	2016-06-07
HWQ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Shoulder Instrument	2016-06-07
HTR INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Shoulder Instrument	2016-06-07
HTE INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Shoulder Instrument	2016-06-07
GDG INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Shoulder Instrument	2016-06-07
PMN K050275 | HTY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Pin	2015-10-21
PMN K151360 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Spinal Graft Containment System	2015-10-09
PMN K151360 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion S-2 Accessory Instrument	2015-10-09
PMN K151360 Inion Oy	Inion Spinal Graft Containment System	2015-10-06
HXD INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion ACL Instrument	2015-07-21
HTO INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion ACL Instrument	2015-07-21
HRT INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion ACL Instrument	2015-07-21
PMN K133932 | HTY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion FreedomPin	2014-04-24
PMN K133932 INION OY	INION FREEDOMPIN	2014-04-11
OJH INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instruments	2013-05-17
PMN K123672 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion FreedomScrew	2013-03-04
PMN K122890 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion CPS Orbital Plates	2013-03-04
PMN K122890 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion CPS Instrument	2013-03-04
PMN K123672 INION OY	INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)	2013-02-27
PMN K122890 INION OY	INION CPS ORBITAL PLATES	2013-01-29
FZT INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-02-14
PMN K071810 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion S-2 Accessory Instrument	2011-01-27
PMN K071810 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion S-1 Accessory Instrument	2011-01-27
PMN K071810 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Biodegradable Spinal Graft Containment System	2011-01-27
PMN K071464 | MAI INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Biodegradable ACL/PCL Screw	2011-01-27
PMN K071464 | MAI INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Accessory Instrument	2011-01-27
PMN K071464 | JDR INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Biodegradable ACL/PCL Screw	2011-01-27
PMN K071464 | JDR INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Accessory Instrument	2011-01-27
PMN K071464 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Biodegradable ACL/PCL Screw	2011-01-27
PMN K071464 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Accessory Instrument	2011-01-27
PMN K070998 | MQV INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion BioRestore Synthetic Bone Graft Substitute	2011-01-27
PMN K070784 | LYC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion BioRestore Synthetic Bone Graft Substitute	2011-01-27
PMN K063410 | HRS INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion FreedomPlate	2011-01-27
PMN K052624 | HRS INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Distal Radius Plate	2011-01-27
PMN K051821 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion S-1 accessory instruments	2011-01-27
PMN K051821 | OJB INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion S-1 Anterior Cervical Fusion System for Graft Containm	2011-01-27
PMN K043142 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Mini Screws	2011-01-27
PMN K043142 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K033074 | NPK INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion GTR Biodegradable Membrane System	2011-01-27
PMN K033074 | NPK INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion GTR Accessory Instrument	2011-01-27
PMN K031961 | HRS INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Mesh Biodegradable Plating System	2011-01-27
PMN K031714 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Trinion Biodegradable Meniscus Screw	2011-01-27
PMN K031714 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Trinion Accessory Instrument	2011-01-27
PMN K031712 | HTY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Pin	2011-01-27
PMN K030900 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Fixation System	2011-01-27
PMN K030900 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K023887 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Mini Plating System	2011-01-27
PMN K023887 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K023887 | HRS INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion OTPS Biodegradable Mini Plating System	2011-01-27
PMN K023887 | HRS INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K021280 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Hexalon Biodegradable ACL/PCL Screw	2011-01-27
PMN K020266 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K020266 | HWC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion CPS Biodegradable BSSO Screw	2011-01-27
PMN K010352 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K010352 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion CPS Biodegradable Fixation System	2011-01-27
PMN K010351 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrument	2011-01-27
PMN K010351 | JEY INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion CPS Baby Biodegradable Fixation System	2011-01-27
NBH INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
LXH INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
LRP INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
IRQ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Thermo+ Waterbath	2011-01-27
IRQ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Thermo Waterbath	2011-01-27
HXX INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HXP INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HXJ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HXC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HWX INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HWW INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HWT INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HWJ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HWD INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HTW INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HTJ INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
HTC INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
FZX INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
EIF INION OY [Beijing Naton Technology Group Co. Ltd.]	Inion Instrumentation	2011-01-27
PMN K090177 INION OY	INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE	2009-02-20
PMN K070998 INION OY	INION BIORESTORE	2007-10-11
PMN K071464 INION OY	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	2007-08-03
PMN K070784 INION OY	INION BIORESTORE	2007-07-24
PMN K062782 INION OY	INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001	2006-11-09
PMN K051362 INION OY	INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000	2005-08-04

Related Finance Registrations

NCAGE Code	A274G	INION OY
CAGE Code	A274G	INION OY