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Inion, Ltd.

Active in EUDAMED

Registered as Inion Oy in EUDAMED

Finlandfrom SRN EUDAMED SRN FI-MF-000000646

Part of Inion Oy

Devices
1,517
Registrations
EUDAMED
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA recalls

What Inion, Ltd. makes

Inion, Ltd. manufactures bioabsorbable orthopaedic and spinal fixation devices, including bone screws, fixation plates, and pins designed to degrade over time. Their portfolio also includes reusable surgical tools like bone taps and implant templates, as well as synthetic polymer-based extra-gynaecological surgical mesh. These products are intended for orthopaedic and spinal applications where temporary structural support is required.

The company’s devices are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Inion, Ltd. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1,517

Newest first, rows 1-50 of 1,517

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  • Inion CompressOn™ / Inion FreedomScrew™ Instrument 1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Inion CompressOn™ / Inion FreedomScrew™ Instrument 1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Inion CompressOn™ Screw Instrumentation Ref IFS-9069

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Inion FreedomPin™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.0 mm Inion CPS® 1

    Withdrawn Registry: GUDID Class:II

  • 1.5 mm Inion OTPS™

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion BioRestore™ 1

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:II

  • 2.8 mm Inion CPS® 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion CPS BioRestore™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion OTPS™ Biodegradable Screw 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion OTPS BioRestore™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 1.5 mm Inion CPS®

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.0 mm Inion OTPS™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 1.5 mm Inion CPS® Baby

    Withdrawn Registry: GUDID Class:II

  • Inion instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion CPS FreedomPlate™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.0 mm Inion CPS® 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion instrument 0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion SPINE instrumentation 1

    Withdrawn Registry: GUDID Class:I

  • Inion Hexalon™ ACL/PCL Screw 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.0 mm Inion OTPS™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.0 mm Inion CPS® 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2 instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion CPS FreedomPlate™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion instrument 0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-1™

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 1.5 mm Inion CPS®

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2 instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion OTPS™ Biodegradable Screw 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion OTPS™ Biodegradable Screw 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2 instrument 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-1™

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 2.5 mm Inion CPS® 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion FreedomScrew™ 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion Hexalon™ ACL/PCL Screw 1

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Inion S-1™

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2 instrument 0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion BioRestore™ 1

    Listed Registry: GUDID Class:II

  • 2.5 mm Inion CPS® 1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion S-2 instrument 0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Inion SPINE instrumentation 1

    Withdrawn Registry: GUDID Class:I

Rows 1-50 of 1,517

Showing 1-50 of 1,517

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FI-MF-000000646
EU VAT number
FI23705679
EUDAMED status
Active
EUDAMED registered name
Inion Oy
Registered address
2, Lääkärinkatu, 33520, Tampere, Finland
Website
www.inion.com
PRRC contact
Kati Marttinen(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jun 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 729135 Expiring Supplemented Expires in 222 days

    Quality management system EU MDR

    Issued
    24 Sep 2026
    Expires
    21 Jun 2027
    Reason
    Change approved

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Inion, Ltd., initiated on 2017-03-01. By recorded status: 1 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2017

    • 1 Mar 2017 Z-1478-2017 Class II Terminated Aluminum pouch seal was noticed to be defective (slightly open). Distribution: US Distribution to : FL and NC. Submission number: K033074

Frequently asked questions

How many devices does Inion, Ltd. have in the registry?

The registry currently lists 1517 devices for Inion, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Inion, Ltd.'s devices?

Among its 50 most recently registered devices, Inion, Ltd. has devices listed in EUDAMED (5 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Inion, Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Inion, Ltd.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Inion, Ltd.?

FDA recall records list 1 recall initiated by Inion, Ltd., the most recent initiated on 1 Mar 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Inion, Ltd.?

EUDAMED lists 1 certificate for Inion, Ltd. (quality management system) under MDR. The most recent was issued on 24 Sep 2026.

What are the newest devices from Inion, Ltd. in the registry?

The most recently registered devices listed for Inion, Ltd. include Inion CompressOn™ / Inion FreedomScrew™ Instrument 1, Inion CompressOn™ Screw Instrumentation, Inion FreedomPin™ 1 and Inion FreedomScrew™ 1.

Generated automatically from registry data and not verified by a human reviewer.