E-MATRIX GRAFT BONE EXTENDER— 510(k) K083449

Name: FDA 510(k) clearance K083449
Creator: U.S. Food and Drug Administration
Published: 2009-06-12

Substantially Equivalent

Pioneer Surgical Technology

FDA 510(k) clearance K083449 for E-MATRIX GRAFT BONE EXTENDER, Substantially Equivalent on 2009-06-12. Applicant: Pioneer Surgical Technology. Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2008-11-21
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

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K253524 — Adaptos®Fuse Bone Graft2026-02-17

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.