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Crosscheck Plating System

by Solana Surgical, LLC

510(k) K132594

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

21 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 NumberK132594 Date13 Dec 2013ClearedStatusActive

Recalls

21 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2541-2015 FDA Class II initiated 21 Jul 2015
    • Terminated Z-2542-2015 FDA Class II initiated 21 Jul 2015

    These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.

  • 15 recalls, same reason

    • Terminated Z-1487-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1491-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1488-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1494-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1484-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1498-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1489-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1485-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1490-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1495-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1492-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1496-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1497-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1486-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1493-2015 FDA Class II initiated 6 Mar 2015

    The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

  • 4 recalls, same reason

    • Terminated Z-1500-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1483-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1499-2015 FDA Class II initiated 6 Mar 2015
    • Terminated Z-1482-2015 FDA Class II initiated 6 Mar 2015

    The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.

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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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