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FDA 510(k)

CarboClear® II Pedicle Screw System

K-Number: K200519 · 2020-04-30

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2020-04-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear® II Pedicle Screw System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-04-30 under approval number K200519. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear® II Pedicle Screw System?

CarboClear® II Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-04-30. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K200519.

When was CarboClear® II Pedicle Screw System approved by the FDA?

CarboClear® II Pedicle Screw System received FDA 510(k) clearance on 2020-04-30, under approval number K200519.

What company makes CarboClear® II Pedicle Screw System?

CarboClear® II Pedicle Screw System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear® II Pedicle Screw System?

The FDA product code for CarboClear® II Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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