K231280

Substantially Equivalent

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement

Applicant: CarboFix Orthopedics , Ltd.
Product code: NKB
Advisory panel: Orthopedic
Date received: 2023-05-03
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzeliya, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.