SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35— 510(k) K120557

Substantially Equivalent

Biomet Spine & Bone Healing Technologies

FDA 510(k) clearance K120557 for SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35, Substantially Equivalent on 2012-03-19. Applicant: Biomet Spine & Bone Healing Technologies.

Clearance details

Applicant: Biomet Spine & Bone Healing Technologies
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2012-02-24
Decision date: 2012-03-19
Decision: Substantially Equivalent
Clearance type: Special
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.