EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE— 510(k) K050675

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K050675 for EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE, Substantially Equivalent on 2005-04-11. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2005-03-16
Decision date: 2005-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.