Additive Orthopaedics Patient Specific 3D Locking Lattice Plates— 510(k) K183011

Substantially Equivalent

Additive Orthopaedics

FDA 510(k) clearance K183011 for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates, Substantially Equivalent on 2019-01-10. Applicant: Additive Orthopaedics.

Clearance details

Applicant: Additive Orthopaedics
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2018-10-31
Decision date: 2019-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Beach, 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.