PICCOLO COMPOSITE PLATE SYSTEM— 510(k) K130061

Substantially Equivalent

CarboFix Orthopedics , Ltd.

FDA 510(k) clearance K130061 for PICCOLO COMPOSITE PLATE SYSTEM, Substantially Equivalent on 2013-02-27. Applicant: CarboFix Orthopedics , Ltd..

Clearance details

Applicant: CarboFix Orthopedics , Ltd.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-01-10
Decision date: 2013-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Herzliya, IL

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.