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510(k) K231809

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement by Ulrich Medical USA — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2023
Date Received
June 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

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  • 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 PML

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  • K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement (June 23, 2023)
  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 2023)
  • K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System (December 20, 2022)
  • K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (August 26, 2022)
  • K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System (October 28, 2021)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K201362 — CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone (August 19, 2020)
  • K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal Syste (March 31, 2020)