MODIFIED VERTIFLEX SPINAL SCREW SYSTEM— 510(k) K073143

Name: FDA 510(k) clearance K073143
Creator: U.S. Food and Drug Administration
Published: 2008-04-07

Substantially Equivalent

Vertiflex, Inc.

FDA 510(k) clearance K073143 for MODIFIED VERTIFLEX SPINAL SCREW SYSTEM, Substantially Equivalent on 2008-04-07. Applicant: Vertiflex, Inc.. Device class: 2.

Clearance details

Applicant: Vertiflex, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2007-11-07
Decision date: 2008-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clamente, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vertiflex, Inc.

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K122509 — VERTIFLEX SPINOUS PROCESS FIXATION PLATE2012-12-17
K122662 — VERTIFLEX DIRECT DECOMPRESSION SYSTEM2012-11-13
K082270 — OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM2008-09-16
K073245 — EXTENDED VERTIFLEX SPINAL SCREW SYSTEM2008-02-15

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.