MotoCLIP/HiMAX Step Staple Implant System— 510(k) K181866

Substantially Equivalent

Crossroads Extremity Systems, LLC

FDA 510(k) clearance K181866 for MotoCLIP/HiMAX Step Staple Implant System, Substantially Equivalent on 2018-08-09. Applicant: Crossroads Extremity Systems, LLC.

Clearance details

Applicant: Crossroads Extremity Systems, LLC
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2018-07-12
Decision date: 2018-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.