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Intrepid Spinal System

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K080083

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK080083 Date10 Apr 2008ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1798-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1803-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1800-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1802-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1796-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1799-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1797-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1801-2009 FDA Unclassified (pre-2012) initiated 6 Feb 2009

    The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

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  • Withdrawn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
MAX
FDA applicant
Medtronic Sofamor Danek
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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