PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)— 510(k) K043206

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K043206 for PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER), Substantially Equivalent on 2005-01-21. Applicant: Pioneer Surgical Technology.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2004-11-19
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, 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.