Black Diamond POCT Spinal System— 510(k) K222107

Substantially Equivalent

Osseus Fusion Systems

FDA 510(k) clearance K222107 for Black Diamond POCT Spinal System, Substantially Equivalent on 2022-11-03. Applicant: Osseus Fusion Systems.

Clearance details

Applicant: Osseus Fusion Systems
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2022-07-18
Decision date: 2022-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.