Skip to content

Kronner Universal Frame External Fixation

by Kronner Medical 510(k)

Active United States

510(k) K871247

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871247 Date22 May 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1587-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1581-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1582-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1600-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1584-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1601-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1578-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1580-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1591-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1590-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1595-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1594-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1593-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1596-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1598-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1592-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1589-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1585-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1579-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1602-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1583-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1599-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1588-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1597-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)
    • Terminated Z-1586-2014 FDA Class II initiated 24 Apr 2014 via K871247, on the same 510(k)

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Kronner Medical