PIONEER STERNAL CABLE PLATE SYSTEM— 510(k) K122293

Name: FDA 510(k) clearance K122293
Creator: U.S. Food and Drug Administration
Published: 2012-10-12

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K122293 for PIONEER STERNAL CABLE PLATE SYSTEM, Substantially Equivalent on 2012-10-12. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2012-07-31
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.