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Lancer Pedicle Screw System

by Spinal Solutions, LLC

510(k) K110633

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Special NumberK110633 Date15 Dec 2011ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1415-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1412-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1413-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1410-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1409-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1414-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1416-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633
    • Terminated Z-1411-2013 FDA Class II initiated 20 Feb 2013 on shared 510(k) K110633

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

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  • Withdrawn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