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

Name: FDA 510(k) clearance K070218
Creator: U.S. Food and Drug Administration
Published: 2007-04-06

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. Device class: 2.

Clearance details

Applicant: Vertiflex (Tm), Incorporated
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
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 ↗

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K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

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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.