CANNULATED SCREW SYSTEM— 510(k) K003496

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K003496 for CANNULATED SCREW SYSTEM, Substantially Equivalent on 2001-02-08. Applicant: Pioneer Surgical Technology.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2000-11-13
Decision date: 2001-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.