OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME— 510(k) K123832

Substantially Equivalent

The Orthopaedic Implant Company (Oic)

FDA 510(k) clearance K123832 for OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME, Substantially Equivalent on 2013-03-20. Applicant: The Orthopaedic Implant Company (Oic).

Clearance details

Applicant: The Orthopaedic Implant Company (Oic)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2012-12-13
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, 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.