VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)— 510(k) K070218

Substantially Equivalent

Vertiflex (Tm), Incorporated

FDA 510(k) clearance K070218 for VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR), Substantially Equivalent on 2007-04-06. Applicant: Vertiflex (Tm), Incorporated.

Clearance details

Applicant: Vertiflex (Tm), Incorporated
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2007-01-23
Decision date: 2007-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.