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Inion CPS Instrumentation

by Inion Oy 4 variants

Ref INS-9279

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06438408012136 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6438408INION-IIA-INSTRUUR Basic UDI-DI 06438408012136UDI-DIDate8 Nov 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0630-2011 FDA Unclassified (pre-2012) initiated 14 Apr 2010
    • Terminated Z-0631-2011 FDA Unclassified (pre-2012) initiated 14 Apr 2010

    Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.

    • Terminated Z-1550-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010 on shared 510(k) K010352

    During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Bone tap, reusable
Device Name
Inion Instruments
Model / Ref / Catalog
INS-9279, 1
Primary DI / UDI-DI
06438408012136
Basic UDI-DI
6438408INION-IIA-INSTRUUR
510(k) Number
FDA Product Code
JEY
EMDN Code
L098003 Orthopaedic and traumatological surgery taps, reusable
GMDN Term
Bone tap, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4760
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
INS-9279
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000000646

Other devices from Inion, Ltd.

See all devices from Inion, Ltd. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No