Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System— 510(k) K191793

Substantially Equivalent

Nebula Surgical Private Limited

FDA 510(k) clearance K191793 for Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System, Substantially Equivalent on 2019-12-09. Applicant: Nebula Surgical Private Limited.

Clearance details

Applicant: Nebula Surgical Private Limited
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2019-07-03
Decision date: 2019-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rajkot, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.