Skip to content

Ebi Periarticular Plating System

by Ebi, L.P. 510(k)

Active United States

510(k) K042237

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042237 Date16 Sep 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-2299-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2295-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2293-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2290-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2298-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2292-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2297-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2294-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2291-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237
    • Terminated Z-2296-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009 on shared 510(k) K042237

    Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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

Other devices from Ebi, L.P.

See all devices from Ebi, L.P. →