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)

HexaPLUS S OneDrill Implant System

K-Number: K243078 · 2025-10-10

ApplicantOsseofuse International, Inc.
Decision Date2025-10-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HexaPLUS S OneDrill Implant System is a medical device manufactured by Osseofuse International, Inc.. It received FDA 510(k) clearance on 2025-10-10 under approval number K243078. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HexaPLUS S OneDrill Implant System?

HexaPLUS S OneDrill Implant System is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Osseofuse International, Inc.. The 510(k) number is K243078.

When was HexaPLUS S OneDrill Implant System approved by the FDA?

HexaPLUS S OneDrill Implant System received FDA 510(k) clearance on 2025-10-10, under approval number K243078.

What company makes HexaPLUS S OneDrill Implant System?

HexaPLUS S OneDrill Implant System is manufactured by Osseofuse International, Inc..

What is the FDA product code for HexaPLUS S OneDrill Implant System?

The FDA product code for HexaPLUS S OneDrill Implant System is DZE.

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 Osseofuse International, Inc.

K181157Conical Plus Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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.

↑