PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM— 510(k) K121725

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K121725 for PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM, Substantially Equivalent on 2012-11-07. Applicant: Pioneer Surgical Technology, Inc..

Clearance details

Applicant: Pioneer Surgical Technology, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2012-06-12
Decision date: 2012-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.