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Codman Intracranial Bolt

by Johnson & Johnson Professionals, Inc.

510(k) K974088

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 NumberK974088 Date9 Jan 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1279-2012 FDA Not yet classified initiated 9 Feb 2012

    Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill

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  • Withdrawn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
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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