Home / 510(k) Clearances / K143626

510(k) K143626

inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System by Zimmer Spine, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
December 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Zimmer Spine, Inc.

  • K153631 — Zimmer Virage OCT Spinal Fixation System (February 16, 2016)
  • K150896 — Vitality Spinal Fixation System (August 31, 2015)
  • K151031 — Virage OCT Spinal Fixation System (June 24, 2015)
  • K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation Syst (June 18, 2015)
  • K143297 — Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Int (February 12, 2015)
  • K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (October 29, 2014)
  • K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM (September 23, 2014)
  • K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM (June 2, 2014)
  • K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)
  • K133184 — ARDIS INTERBODY SYSTEM (January 30, 2014)

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  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)