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510(k) K231280

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement by CarboFix Orthopedics , Ltd. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
May 3, 2023
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 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)
  • 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)
  • K201926 — CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System (August 7, 2020)

Other clearances for product code NKB

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  • 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)