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Cps 1.5/2.0/2.5 Bioabsorbable Fixation System

by Inion Oy

510(k) K010352

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010352 Date14 Mar 2001ClearedStatusActive

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JEY
FDA applicant
Inion , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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