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Timesh System

by Sofamor Danek USA, Inc.

510(k) K974017

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK974017 Date16 Jan 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0849-06 FDA Unclassified (pre-2012) initiated 8 Mar 2006 on shared 510(k) K974017

    Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.

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  • Withdrawn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
HRS
FDA applicant
Sofamor Danek USA,Inc.
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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