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Ceramic Tipped Skull Pin

by The Jerome Group, Inc.

510(k) K040363

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040363 Date12 Apr 2004ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0998-2019 FDA Class II initiated 21 Jun 2018

    Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

  • 3 recalls, same reason

    • Terminated Z-0595-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008
    • Terminated Z-0596-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008
    • Terminated Z-0594-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008

    Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.

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  • Withdrawn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

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