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Eska Modular Hip System Cemented

by Eska Implants GmbH 510(k)

Active United States

510(k) K030867

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030867 Date22 Sep 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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