CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION— 510(k) K081564

Name: FDA 510(k) clearance K081564
Creator: U.S. Food and Drug Administration
Published: 2008-06-30

Substantially Equivalent

Creaspine

FDA 510(k) clearance K081564 for CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION, Substantially Equivalent on 2008-06-30. Applicant: Creaspine. Device class: 2.

Clearance details

Applicant: Creaspine
Product code: Product code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2008-06-04
Decision date: 2008-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, 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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K080860 — CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM2008-05-29

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.