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510(k) K191932

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2019
Date Received
July 19, 2019
Clearance Type
Traditional
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

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  • 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)
  • 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)
  • 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)