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Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K102429

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102429 Date23 Nov 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0563-2020 FDA Class II initiated 8 Nov 2016 on shared 510(k) K102429

    The firm discovered a lack of adequate documentation confirming sterility on certain products.

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

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