Home / 510(k) Clearances / K240515

510(k) K240515

uNion® MAX Cervical Plate System by Ulrich Medical USA, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2024
Date Received
February 23, 2024
Clearance Type
Special
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 Ulrich Medical USA, Inc.

  • K252087 — Navigation Module of the Cortium® System (February 3, 2026)
  • K251719 — Momentum® Posterior Spinal Fixation System (July 1, 2025)
  • K241396 — uCerv Flux™-C 3D Porous Titanium Cervical Interbody (May 23, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K230614 — Cortium™ (May 2, 2023)
  • K223274 — Momentum® MIS Posterior Spinal Fixation System (November 28, 2022)
  • K220696 — uCerv Flux-C 3D Porous Titanium Cervical Interbody (August 19, 2022)
  • K200845 — Navigation Module of the Momentum System (September 10, 2020)
  • K191932 — Momentum™ Posterior Spinal Fixation System (October 2, 2019)
  • K181921 — Solidity Vertebral Body Replacement (November 16, 2018)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • 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)