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Oti Bone Cement Plug

by Osteoimplant Technology, Inc.

510(k) K030608

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK030608 Date12 Jun 2003ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0306-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007
    • Terminated Z-0311-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007
    • Terminated Z-0308-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007
    • Terminated Z-0309-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007
    • Terminated Z-0310-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007
    • Terminated Z-0307-2008 FDA Unclassified (pre-2012) initiated 19 Sep 2007

    Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

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  • Withdrawn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
JDK
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESU

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