510(k) K093629— SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM

Substantially Equivalent

Biomet Spine

Clearance details

Applicant: Biomet Spine
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2009-11-23
Decision date: 2010-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.