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Transfx External Fixation System

by Immedica, Inc.

510(k) K984357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984357 Date4 Mar 1999ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1534-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1537-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1536-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1538-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1532-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1535-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1533-2009 FDA Unclassified (pre-2012) initiated 1 May 2009

    Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

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  • Withdrawn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
LXT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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