Black Diamond Pedicle Screw System— 510(k) K192121

Substantially Equivalent

Osseus Fusion Systems

FDA 510(k) clearance K192121 for Black Diamond Pedicle Screw System, Substantially Equivalent on 2019-10-29. Applicant: Osseus Fusion Systems.

Clearance details

Applicant: Osseus Fusion Systems
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2019-08-06
Decision date: 2019-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.