Inion Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
37
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1478-2017Class IIInion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment oMarch 1, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SysteNovember 7, 2025
K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SysteJuly 11, 2025
K203105Inion CompressOn ScrewJanuary 13, 2021
K191764Inion BioRestoreJuly 31, 2019
K151360Inion Spinal Graft Containment SystemOctober 6, 2015
K133932INION FREEDOMPINApril 11, 2014
K123672INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)February 27, 2013
K122890INION CPS ORBITAL PLATESJanuary 29, 2013
K090177INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTEFebruary 20, 2009
K071810INION SPINAL GRAFT CONTAINMENT SYSTEMJuly 11, 2008
K070998INION BIORESTOREOctober 11, 2007
K071464INION HEXALON BIODEGRADABLE ACL/PCL SCREWAugust 3, 2007
K070784INION BIORESTOREJuly 24, 2007
K063410INION CPS/OTPS FREEDOMPLATEJanuary 23, 2007
K062782INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001November 9, 2006
K062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMOctober 4, 2006
K060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWMarch 13, 2006
K051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMNovember 25, 2005
K052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATENovember 16, 2005
K052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMSeptember 20, 2005