PIONEER CROSSFUSE II IBF/VBR SYSTEM— 510(k) K112496

Name: FDA 510(k) clearance K112496
Creator: U.S. Food and Drug Administration
Published: 2011-09-28

Substantially Equivalent

Pioneer Surgical Technology, Inc.

FDA 510(k) clearance K112496 for PIONEER CROSSFUSE II IBF/VBR SYSTEM, Substantially Equivalent on 2011-09-28. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc.
Product code: Product code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-08-29
Decision date: 2011-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.