ICONACY(TM) I-Hip (TM)— 510(k) K151307

Substantially Equivalent

Iconacy Orthopedic Implants, LLC

FDA 510(k) clearance K151307 for ICONACY(TM) I-Hip (TM), Substantially Equivalent on 2016-02-26. Applicant: Iconacy Orthopedic Implants, LLC.

Clearance details

Applicant: Iconacy Orthopedic Implants, LLC
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2015-05-18
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.