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Eaum Total Knee System

by Corentec Co., Ltd

510(k) K110404

Eaum Total Knee System is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K110404 on 16 Feb 2012, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110404 Date16 Feb 2012ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1935-2024 FDA Class II initiated 29 Mar 2024
    • Ongoing Z-1934-2024 FDA Class II initiated 29 Mar 2024

    Due to unsupported 10 year expiration date.

Timeline

3 dated events

  1. Cleared FDA 510(k) K110404
  2. Recall initiated FDA recalls Z-1935-2024
  3. Recall initiated FDA recalls Z-1934-2024

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  • Withdrawn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
JWH
FDA applicant
Corentec Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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