Inion , Ltd.
Medical device manufacturer in Tampere, FI.
37510(k) clearances
0PMA approvals
1recalls
Device types
- HWC Screw, Fixation, Bone 12
- JEY Plate, Bone 8
- HTY Pin, Fixation, Smooth 3
- HRS Plate, Fixation, Bone 3
- OJB Resorbable Spinal Intervertebral Body… 3
- MQV Filler, Bone Void, Calcium Compound 3
- MAI Fastener, Fixation, Biodegradable, Soft… 2
- NPK Barrier, Synthetic, Intraoral 1
- LYC Bone Grafting Material, Synthetic 1
- HBW Fastener, Plate, Cranioplasty 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | 11/07/2025SE |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…HBW · Traditional | 07/11/2025SE |
| K203105 | Inion CompressOn ScrewHWC · Traditional | 01/13/2021SE |
| K191764 | Inion BioRestoreMQV · Special | 07/31/2019SE |
| K151360 | Inion Spinal Graft Containment SystemOJB · Traditional | 10/06/2015SESU |
| K133932 | Inion FreedompinHTY · Traditional | 04/11/2014SE |
| K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)HWC · Traditional | 02/27/2013SE |
| K122890 | Inion CPS Orbital PlatesJEY · Traditional | 01/29/2013SE |
| K090177 | Inion Biorestore Biodegradable Bone Graft SubstituteMQV · Special | 02/20/2009SE |
| K071810 | Inion Spinal Graft Containment SystemOJB · Traditional | 07/11/2008SESU |
| K070998 | Inion BiorestoreMQV · Traditional | 10/11/2007SE |
| K071464 | Inion Hexalon Biodegradable Acl/Pcl ScrewHWC · Traditional | 08/03/2007SE |
| K070784 | Inion BiorestoreLYC · Traditional | 07/24/2007SE |
| K063410 | Inion Cps/Otps FreedomplateHRS · Traditional | 01/23/2007SE |
| K062782 | Inion Anchron Plus Biodegradable Anchor System, Model ANC-6001MAI · Special | 11/09/2006SE |
| K062617 | Modification to Inion Otps Biodegradable Fixation SystemHWC · Special | 10/04/2006SE |
| K060393 | Inion Hexalon Biodegradable Acl/Pcl ScrewHWC · Special | 03/13/2006SE |
| K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion SystemOJB · Traditional | 11/25/2005SE |
| K052624 | Inion Otps Biodegradable Distal Radius PlateHRS · Traditional | 11/16/2005SE |
| K052444 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemJEY · Special | 09/20/2005SE |
| K051362 | Inion Anchron Biodegradable Anchor System, Model ANC-6000MAI · Traditional | 08/04/2005SE |
| K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058…JEY · Special | 05/27/2005SE |
| K050275 | Modification to: Inion Otps Biodegradable PinHTY · Special | 03/07/2005SE |
| K043142 | Inion Otps Biodegradable Mini Plating SystemHWC · Traditional | 02/18/2005SE |
| K031714 | Inion Trinion Biodegradable Meniscus ScrewHWC · Traditional | 08/16/2004SE |
| K033074 | Inion GTR Biodegradable Membrane SystemNPK · Traditional | 03/31/2004SE |
| K031961 | Inion Otps Biodegradable Mesh Plating SystemHRS · Traditional | 03/01/2004SE |
| K033194 | Inion CPS Baby 1.5 Bioabsorbable SystemJEY · Special | 10/30/2003SE |
| K031712 | Inion Otps Biodegradable PinHTY · Traditional | 08/28/2003SE |
| K030900 | Inion Otps Biodegradable Fixaton SystemHWC · Traditional | 06/19/2003SE |
| K023887 | Inion Otps Biodegradable Mini Plating SystemHWC · Traditional | 05/30/2003SE |
| K022981 | Inion CPS 2.5/2.8 ScrewHWC · Special | 09/12/2002SE |
| K021280 | Inion Hexalon Biodegradable Acl/Pcl ScrewHWC · Traditional | 07/17/2002SE |
| K020266 | Inion CPS Bsso ScrewHWC · Special | 02/22/2002SE |
| K013039 | Inion CPS 2.0 Orthognathic PlateJEY · Special | 10/05/2001SE |
| K010351 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemJEY · Traditional | 03/15/2001SE |
| K010352 | CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemJEY · Traditional | 03/14/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1478-2017 Class II | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical…Aluminum pouch seal was noticed to be defective (slightly open). | 03/01/2017Terminated |