PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)— 510(k) K061151

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K061151 for PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER), Substantially Equivalent on 2006-07-24. Applicant: Pioneer Surgical Technology.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2006-04-25
Decision date: 2006-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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.