Tritium Sternal Cable Plate System— 510(k) K150581

Name: FDA 510(k) clearance K150581
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Substantially Equivalent

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

FDA 510(k) clearance K150581 for Tritium Sternal Cable Plate System, Substantially Equivalent on 2015-06-04. Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2015-03-09
Decision date: 2015-06-04
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 JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.