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

FDA 510(k)

TriMAX Implant System

K-Number: K190722 · 2019-08-16

ApplicantCrossroads Extemity Systems, LLC
Decision Date2019-08-16
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMAX Implant System is a medical device manufactured by Crossroads Extemity Systems, LLC. It received FDA 510(k) clearance on 2019-08-16 under approval number K190722. 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 TriMAX Implant System?

TriMAX Implant System is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Crossroads Extemity Systems, LLC. The 510(k) number is K190722.

When was TriMAX Implant System approved by the FDA?

TriMAX Implant System received FDA 510(k) clearance on 2019-08-16, under approval number K190722.

What company makes TriMAX Implant System?

TriMAX Implant System is manufactured by Crossroads Extemity Systems, LLC.

What is the FDA product code for TriMAX Implant System?

The FDA product code for TriMAX Implant System is JDR.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

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 Extemity Systems, LLC

K191342CrossRoads Screw System K193452MotoBAND CP Implant System

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.

↑