510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Inion Oy

TAMPERE Pirkanmaa, FI

INION OY appears in FDA device records in TAMPERE Pirkanmaa, FI. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
37
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 37 510(k) clearances for Inion Oy between 2001 and 2025. The busiest year on record is 2005, with 7. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Inion Oy, by decision year
YearClearances
20013
20023
20034
20043
20057
20063
20074
20081
20091
20132
20141
20151
20191
20211
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemJEYSubstantially Equivalent
K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemHBWSubstantially Equivalent
K203105Inion CompressOn ScrewHWCSubstantially Equivalent
K191764Inion BioRestoreMQVSubstantially Equivalent
K151360Inion Spinal Graft Containment SystemOJBUnknown
K133932INION FREEDOMPINHTYSubstantially Equivalent
K123672INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)HWCSubstantially Equivalent
K122890INION CPS ORBITAL PLATESJEYSubstantially Equivalent
K090177INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K071810INION SPINAL GRAFT CONTAINMENT SYSTEMOJBUnknown
K070998INION BIORESTOREMQVSubstantially Equivalent
K071464INION HEXALON BIODEGRADABLE ACL/PCL SCREWHWCSubstantially Equivalent
K070784INION BIORESTORELYCSubstantially Equivalent
K063410INION CPS/OTPS FREEDOMPLATEHRSSubstantially Equivalent
K062782INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001MAISubstantially Equivalent
K062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMHWCSubstantially Equivalent
K060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWHWCSubstantially Equivalent
K051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMOJBSubstantially Equivalent
K052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATEHRSSubstantially Equivalent
K052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially Equivalent
K051362INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000MAISubstantially Equivalent
K051341INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059JEYSubstantially Equivalent
K050275MODIFICATION TO: INION OTPS BIODEGRADABLE PINHTYSubstantially Equivalent
K043142INION OTPS BIODEGRADABLE MINI PLATING SYSTEMHWCSubstantially Equivalent
K031714INION TRINION BIODEGRADABLE MENISCUS SCREWHWCSubstantially Equivalent
K033074INION GTR BIODEGRADABLE MEMBRANE SYSTEMNPKSubstantially Equivalent
K031961INION OTPS BIODEGRADABLE MESH PLATING SYSTEMHRSSubstantially Equivalent
K033194INION CPS BABY 1.5 BIOABSORBABLE SYSTEMJEYSubstantially Equivalent
K031712INION OTPS BIODEGRADABLE PINHTYSubstantially Equivalent
K030900INION OTPS BIODEGRADABLE FIXATON SYSTEMHWCSubstantially Equivalent
K023887INION OTPS BIODEGRADABLE MINI PLATING SYSTEMHWCSubstantially Equivalent
K022981INION CPS 2.5/2.8 SCREWHWCSubstantially Equivalent
K021280INION HEXALON BIODEGRADABLE ACL/PCL SCREWHWCSubstantially Equivalent
K020266INION CPS BSSO SCREWHWCSubstantially Equivalent
K013039INION CPS 2.0 ORTHOGNATHIC PLATEJEYSubstantially Equivalent
K010351INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially Equivalent
K010352CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially Equivalent

Registered establishments

FDA registered establishments for Inion Oy, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97106293003407235INION OYLAAKARINKATU 2, TAMPERE Pirkanmaa 33520 FI2026and 22 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1478-2017Inion 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 procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.Aluminum pouch seal was noticed to be defective (slightly open).Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain