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Maximis Spinal Fixation System

by Valorem Surgical

510(k) K140359

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

100 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 NumberK140359 Date7 Jan 2015ClearedStatusActive

Recalls

100 recalls · FDA

  • 100 recalls, same reason

    • Terminated Z-2880-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3015-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2901-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3016-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2962-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3006-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2995-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2933-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3005-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3014-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2926-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2891-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2994-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2987-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2927-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2917-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2979-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2989-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2959-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3008-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2956-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2936-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2984-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2879-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2941-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3002-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2977-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2952-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2885-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2930-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2939-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2935-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2998-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2894-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2886-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2944-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2978-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2951-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2999-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2915-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2893-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2934-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2918-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2928-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2897-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2925-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2919-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2971-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2903-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2875-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2889-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2945-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2982-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2997-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2973-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2924-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2877-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2937-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2961-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2975-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2990-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2963-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2895-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2905-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2923-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2910-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2898-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2873-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2968-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2908-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2876-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2996-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2916-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2940-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2986-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2974-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2993-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2958-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3010-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2878-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2914-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2983-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2882-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2888-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2911-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3004-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2899-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2964-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2949-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2887-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3001-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-3003-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2902-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2967-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2929-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2947-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2992-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2912-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2950-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359
    • Terminated Z-2883-2017 FDA Class II initiated 21 Jun 2017 on shared 510(k) K140359

    Devices are not consistent with Quality System Requirements.

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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent