OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM— 510(k) K082270

Substantially Equivalent

Vertiflex, Inc.

FDA 510(k) clearance K082270 for OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM, Substantially Equivalent on 2008-09-16. Applicant: Vertiflex, Inc..

Clearance details

Applicant: Vertiflex, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-08-11
Decision date: 2008-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Clamente, CA, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.