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510(k) K233944

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments by CarboFix Orthopedics , Ltd. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2024
Date Received
December 14, 2023
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 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)
  • 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)
  • K201926 — CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System (August 7, 2020)

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)