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510(k) K223274

Momentum® MIS Posterior Spinal Fixation System by Ulrich Medical USA — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2022
Date Received
October 24, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Ulrich Medical USA

  • 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)
  • K240515 — uNion® MAX Cervical Plate System (March 18, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K230614 — Cortium™ (May 2, 2023)
  • 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 NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)