ICONACY(TM) I-Hip(TM)— 510(k) K160266

Substantially Equivalent

Iconacy Orthopedic Implants, LLC

FDA 510(k) clearance K160266 for ICONACY(TM) I-Hip(TM), Substantially Equivalent on 2016-04-08. Applicant: Iconacy Orthopedic Implants, LLC.

Clearance details

Applicant: Iconacy Orthopedic Implants, LLC
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2016-02-02
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.