CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM— 510(k) K080860

Substantially Equivalent

Creaspine

FDA 510(k) clearance K080860 for CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM, Substantially Equivalent on 2008-05-29. Applicant: Creaspine.

Clearance details

Applicant: Creaspine
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2008-03-27
Decision date: 2008-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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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.