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510(k) K190526

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws by CarboFix Orthopedics , Ltd. — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2019
Date Received
March 4, 2019
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.

Other clearances by CarboFix Orthopedics , Ltd.

  • K243106 — CarboClear® Hybrid Pedicle Screw System (November 5, 2024)
  • K233793 — CarboClear® X Pedicle Screw System (August 1, 2024)
  • K240846 — CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instrument (April 25, 2024)
  • K233989 — CarboClear® Posterior Cervical Screw System (March 27, 2024)
  • K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (January 10, 2024)
  • K232341 — CarboClear® Pedicle Screw System (October 10, 2023)
  • K231280 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboCl (July 3, 2023)
  • K210716 — CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments (April 6, 2021)
  • K203317 — CarboClear X Pedicle Screw System (November 25, 2020)
  • K201917 — Piccolo Composite Proximal Tibia Plate System (October 8, 2020)

Other clearances for product code PML

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (June 12, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • 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)