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Multiple Nonpowered Neurosurgical Instrument

by Ruggles Corp.

510(k) K902818

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 NumberK902818 Date20 Sep 1990ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2056-2013 FDA Class II initiated 17 Jul 2013

    As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.

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  • Withdrawn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
HBG
Device Class
Class II
Regulation
21 CFR Part 882.4300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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