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Cezanne II Interbody Fusion System

by Accel Spine

510(k) K131981

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK131981 Date9 Oct 2013ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Completed Z-2504-2020 FDA Class II initiated 21 Aug 2019
    • Completed Z-2501-2020 FDA Class II initiated 21 Aug 2019
    • Completed Z-2502-2020 FDA Class II initiated 21 Aug 2019
    • Completed Z-2503-2020 FDA Class II initiated 21 Aug 2019

    Reports received of the device fracturing during insertion.

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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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