SOLITAIRE ANTERIOR SPINAL SYSTEM— 510(k) K081501

Substantially Equivalent

Biomet Spine

FDA 510(k) clearance K081501 for SOLITAIRE ANTERIOR SPINAL SYSTEM, Substantially Equivalent on 2008-07-02. Applicant: Biomet Spine.

Clearance details

Applicant: Biomet Spine
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2008-05-29
Decision date: 2008-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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.