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Mini Maxlock Extreme Plating System

by Orthohelix Surgical Designs, Inc. 3 variants

510(k) K101962

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 NumberK101962 Date27 Sep 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3081-2011 FDA Unclassified (pre-2012) initiated 6 Jul 2011

    The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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