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Cranial Drill Bits and Accessories

by Ad-Tech Medical Instrument Corporation

510(k) K170442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK170442 Date7 Sep 2017ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2544-2019 FDA Class II initiated 27 Aug 2019 on shared 510(k) K170442

    The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

    • Terminated Z-2539-2018 FDA Class II initiated 2 May 2018

    The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

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  • Withdrawn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
HBE
Device Class
Class II
Regulation
21 CFR Part 882.4310
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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