Additive Orthopaedics Patient Specific 3D Printed Bone Segments— 510(k) K180239

Substantially Equivalent

Additive Orthopaedics, LLC

FDA 510(k) clearance K180239 for Additive Orthopaedics Patient Specific 3D Printed Bone Segments, Substantially Equivalent on 2018-05-16. Applicant: Additive Orthopaedics, LLC.

Clearance details

Applicant: Additive Orthopaedics, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2018-01-29
Decision date: 2018-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Silver, NJ, US

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.