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FDA 510(k)

MotoCLIP/HiMAX Implant System

K-Number: K181410 · 2018-06-29

ApplicantCrossroads Extremity Systems, LLC
Decision Date2018-06-29
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MotoCLIP/HiMAX Implant System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-06-29 under approval number K181410. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MotoCLIP/HiMAX Implant System?

MotoCLIP/HiMAX Implant System is a medical device that received FDA 510(k) clearance on 2018-06-29. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K181410.

When was MotoCLIP/HiMAX Implant System approved by the FDA?

MotoCLIP/HiMAX Implant System received FDA 510(k) clearance on 2018-06-29, under approval number K181410.

What company makes MotoCLIP/HiMAX Implant System?

MotoCLIP/HiMAX Implant System is manufactured by Crossroads Extremity Systems, LLC.

What is the FDA product code for MotoCLIP/HiMAX Implant System?

The FDA product code for MotoCLIP/HiMAX Implant System is JDR.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Crossroads Extremity Systems, LLC

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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