PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM— 510(k) K072703

Name: FDA 510(k) clearance K072703
Creator: U.S. Food and Drug Administration
Published: 2008-01-10

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K072703 for PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM, Substantially Equivalent on 2008-01-10. Applicant: Pioneer Surgical Technology. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2007-09-24
Decision date: 2008-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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K260697 — VyPlate Anterior Cervical Plate System2026-03-27

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K093692 — QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES2010-08-11
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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.