Medical Device Manufacturer · FI , Tampere

Inion OY

14 submissions · 13 cleared · Since 2005
14
Total
13
Cleared
0
Denied

Inion OY — FDA 510(k) Submissions

Inion OY has submitted 14 FDA 510(k) premarket notifications since 2005, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Filler, Bone Void, Calcium Compound, Screw, Fixation, Bone, Fastener, Fixation, Biodegradable, Soft Tissue, Plate, Bone, Pin, Fixation, Smooth . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
K251441 · JEY Plate, Bone · Dental
Nov 2025 182d
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251472 · HBW Fastener, Plate,... · Neurology
Jul 2025 59d
Inion CompressOn Screw
K203105 · HWC Screw, Fixation, Bone · Orthopedic
Jan 2021 90d
Inion BioRestore
K191764 · MQV Filler, Bone Void,... · Orthopedic
Jul 2019 30d
Inion Spinal Graft Containment System
K151360 · OJB Resorbable Spinal... · Orthopedic
Oct 2015 139d
INION FREEDOMPIN
K133932 · HTY Pin, Fixation, Smooth · Orthopedic
Apr 2014 109d
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2013 90d
INION CPS ORBITAL PLATES
K122890 · JEY Plate, Bone · Dental
Jan 2013 131d
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
K090177 · MQV Filler, Bone Void,... · Orthopedic
Feb 2009 28d
INION BIORESTORE
K070998 · MQV Filler, Bone Void,... · Orthopedic
Oct 2007 185d
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K071464 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2007 66d
INION BIORESTORE
K070784 · LYC Bone Grafting Material,... · Dental
Jul 2007 125d
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
K062782 · MAI Fastener, Fixation,... · Orthopedic
Nov 2006 52d
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
K051362 · MAI Fastener, Fixation,... · Orthopedic
Aug 2005 71d
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