Medical Device Manufacturer · FI , Tampere

Inion , Ltd.

23 submissions · 22 cleared · Since 2001
23
Total
22
Cleared
0
Denied

Inion , Ltd. — FDA 510(k) Submissions

Inion , Ltd. has submitted 23 FDA 510(k) premarket notifications since 2001, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Screw, Fixation, Bone, Plate, Bone, Plate, Fixation, Bone, Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate, Pin, Fixation, Smooth . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
INION SPINAL GRAFT CONTAINMENT SYSTEM
K071810 · OJB Resorbable Spinal... · Orthopedic
Jul 2008 375d
INION CPS/OTPS FREEDOMPLATE
K063410 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2007 71d
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
K062617 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2006 29d
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K060393 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2006 26d
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
K051821 · OJB Resorbable Spinal... · Orthopedic
Nov 2005 143d
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
K052624 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2005 54d
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K052444 · JEY Plate, Bone · Dental
Sep 2005 14d
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059
K051341 · JEY Plate, Bone · Dental
May 2005 4d
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275 · HTY Pin, Fixation, Smooth · Orthopedic
Mar 2005 28d
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2005 95d
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2004 441d
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · NPK Barrier, Synthetic,... · Dental
Mar 2004 184d
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2004 250d
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · JEY Plate, Bone · Dental
Oct 2003 28d
INION OTPS BIODEGRADABLE PIN
K031712 · HTY Pin, Fixation, Smooth · Orthopedic
Aug 2003 87d
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2003 87d
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · HWC Screw, Fixation, Bone · Orthopedic
May 2003 190d
INION CPS 2.5/2.8 SCREW
K022981 · HWC Screw, Fixation, Bone · Dental
Sep 2002 3d
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2002 86d
INION CPS BSSO SCREW
K020266 · HWC Screw, Fixation, Bone · Dental
Feb 2002 28d
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · JEY Plate, Bone · Dental
Oct 2001 25d
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351 · JEY Plate, Bone · Dental
Mar 2001 37d
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · JEY Plate, Bone · Dental
Mar 2001 36d
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