Skip to the page
Get started – free

Data / Medical devices / Finland / Inion OY

Inion OY: FDA-registered device maker in TAMPERE Pirkanmaa, Finland, 26 510(k) clearances

Inion OY is registered with the FDA (registration 9710629) in TAMPERE Pirkanmaa, Finland. It lists 32 device types. The FDA files 26 510(k) clearances under its listings, the newest dated November 7, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Inion OY
FDA registration number
9710629
FEI number
3003407235
Address
Laakarinkatu 2, TAMPERE Pirkanmaa, Finland, 33520
Owner or operator
Beijing Naton Technology Group Co. Ltd. (10035021)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
January 27, 2011
Registered through
2026
Brand names listed
Inion BioRestore, Inion BioRestore Synthetic Bone Graft Substitute, Inion Biodegradable Spinal Graft Containment System, Inion CPS 1.5/2/2.5 Bioabsorbable Fixation System, Inion CPS Baby 1.5 Bioabsorbable Fixation System, Inion CPS Baby Biodegradable Fixation System, Inion CPS Biodegradable BSSO Screw, Inion CPS Biodegradable Fixation System and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufacturer, Specification developeraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Manufacturer, Specification developeraccessdata.fda.gov
AwlHWJ1Manufacturer, Specification developeraccessdata.fda.gov
Barrier, Synthetic, IntraoralNPK2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufacturer, Specification developeraccessdata.fda.gov
Bone Grafting Material, SyntheticLYC2Manufactureraccessdata.fda.gov
CountersinkHWW1Manufacturer, Specification developeraccessdata.fda.gov
Cutter, SurgicalFZT1Manufacturer, Specification developeraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Manufactureraccessdata.fda.gov
Fastener, Plate, CranioplastyHBW2Manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Contract manufacturer, Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufacturer, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic TrayOJH1Manufacturer, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Manufacturer, Specification developeraccessdata.fda.gov
Resorbable Spinal Intervertebral Body Fixation Orthosis - PlateOJB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufacturer, Specification developeraccessdata.fda.gov
Staple DriverHXJ1Manufacturer, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufacturer, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Manufacturer, Specification developeraccessdata.fda.gov
TemplateHWT1Manufacturer, Specification developeraccessdata.fda.gov
Tray, SurgicalLRP1Manufacturer, Specification developeraccessdata.fda.gov
Unit, Heating, PoweredIRQ1Manufacturer, Specification developeraccessdata.fda.gov
WrenchHXC1Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 7, 2025K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemJEYSubstantially EquivalentInion OYaccessdata.fda.gov
July 11, 2025K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemHBWSubstantially EquivalentInion OYaccessdata.fda.gov
January 13, 2021K203105Inion CompressOn ScrewHWCSubstantially EquivalentInion OYaccessdata.fda.gov
July 31, 2019K191764Inion BioRestoreMQVSubstantially EquivalentInion OYaccessdata.fda.gov
October 6, 2015K151360Inion Spinal Graft Containment SystemOJBUnknownInion OYaccessdata.fda.gov
April 11, 2014K133932INION FREEDOMPINHTYSubstantially EquivalentInion OYaccessdata.fda.gov
February 27, 2013K123672INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)HWCSubstantially EquivalentInion OYaccessdata.fda.gov
January 29, 2013K122890INION CPS ORBITAL PLATESJEYSubstantially EquivalentInion OYaccessdata.fda.gov
July 11, 2008K071810INION SPINAL GRAFT CONTAINMENT SYSTEMOJBUnknownInion , Ltd.accessdata.fda.gov
October 11, 2007K070998INION BIORESTOREMQVSubstantially EquivalentInion OYaccessdata.fda.gov
August 3, 2007K071464INION HEXALON BIODEGRADABLE ACL/PCL SCREWHWCSubstantially EquivalentInion OYaccessdata.fda.gov
July 24, 2007K070784INION BIORESTORELYCSubstantially EquivalentInion OYaccessdata.fda.gov
January 23, 2007K063410INION CPS/OTPS FREEDOMPLATEHRSSubstantially EquivalentInion , Ltd.accessdata.fda.gov
November 25, 2005K051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMOJBSubstantially EquivalentInion , Ltd.accessdata.fda.gov
November 16, 2005K052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATEHRSSubstantially EquivalentInion , Ltd.accessdata.fda.gov
March 7, 2005K050275MODIFICATION TO: INION OTPS BIODEGRADABLE PINHTYSubstantially EquivalentInion , Ltd.accessdata.fda.gov
February 18, 2005K043142INION OTPS BIODEGRADABLE MINI PLATING SYSTEMHWCSubstantially EquivalentInion , Ltd.accessdata.fda.gov
March 31, 2004K033074INION GTR BIODEGRADABLE MEMBRANE SYSTEMNPKSubstantially EquivalentInion , Ltd.accessdata.fda.gov
March 1, 2004K031961INION OTPS BIODEGRADABLE MESH PLATING SYSTEMHRSSubstantially EquivalentInion , Ltd.accessdata.fda.gov
August 28, 2003K031712INION OTPS BIODEGRADABLE PINHTYSubstantially EquivalentInion , Ltd.accessdata.fda.gov
June 19, 2003K030900INION OTPS BIODEGRADABLE FIXATON SYSTEMHWCSubstantially EquivalentInion , Ltd.accessdata.fda.gov
May 30, 2003K023887INION OTPS BIODEGRADABLE MINI PLATING SYSTEMHWCSubstantially EquivalentInion , Ltd.accessdata.fda.gov
July 17, 2002K021280INION HEXALON BIODEGRADABLE ACL/PCL SCREWHWCSubstantially EquivalentInion , Ltd.accessdata.fda.gov
February 22, 2002K020266INION CPS BSSO SCREWHWCSubstantially EquivalentInion , Ltd.accessdata.fda.gov
March 15, 2001K010351INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially EquivalentInion , Ltd.accessdata.fda.gov
March 14, 2001K010352CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially EquivalentInion , Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 1, 201776638Class IITerminatedInion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedurAluminum pouch seal was noticed to be defective (slightly open).accessdata.fda.gov

Compare with other makers

Updated November 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.