Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-06-29 under 510(k) 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. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K181410.

When did MotoCLIP/HiMAX Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for MotoCLIP/HiMAX Implant System?

The FDA 510(k) record lists Crossroads Extremity Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Crossroads Extremity Systems, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253178TRILEAP Plating SystemK241050CrossRoads Modular Tray SystemK230591TriLEAP Plating SystemK223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemK220797FootHold SystemK202268CrossRoads Tray System

View all 13 devices →

Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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.

↑