Osteo-site Vertebral Balloon— 510(k) K200763

Name: FDA 510(k) clearance K200763
Creator: U.S. Food and Drug Administration
Published: 2020-08-12

Substantially Equivalent

Izi Medical

FDA 510(k) clearance K200763 for Osteo-site Vertebral Balloon, Substantially Equivalent on 2020-08-12. Applicant: Izi Medical. Device class: 2.

Clearance details

Applicant: Izi Medical
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2020-03-24
Decision date: 2020-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owings Mills, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.