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Jerome Glass Ring

by The Jerome Group, Inc.

510(k) K023959

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK023959 Date21 Feb 2003ClearedStatusActive

Recalls

6 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1507-2009 FDA Unclassified (pre-2012) initiated 9 Nov 2008
    • Terminated Z-1508-2009 FDA Unclassified (pre-2012) initiated 9 Nov 2008
    • Terminated Z-1509-2009 FDA Unclassified (pre-2012) initiated 9 Nov 2008

    Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.

  • 3 recalls, same reason

    • Terminated Z-0595-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008 on shared 510(k) K023959
    • Terminated Z-0596-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008 on shared 510(k) K023959
    • Terminated Z-0594-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008 on shared 510(k) K023959

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HAX
Device Class
Class II
Regulation
21 CFR Part 882.5960
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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