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Trinica Select Anterior Cervical Plate System

by Centerpulse Spine-Tech, Inc.

510(k) K022344

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 · Special NumberK022344 Date24 Sep 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1014-04 FDA Unclassified (pre-2012) initiated 21 May 2004 on shared 510(k) K022344

    The recalled bone taps could break inside the vertebral body during the tapping process.

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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