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FDA 510(k)

Implant-One System

K-Number: K231455 · 2023-08-15

ApplicantImplant Logistics, Inc.
Decision Date2023-08-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implant-One System is a medical device manufactured by Implant Logistics, Inc.. It received FDA 510(k) clearance on 2023-08-15 under approval number K231455. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Implant-One System?

Implant-One System is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Implant Logistics, Inc.. The 510(k) number is K231455.

When was Implant-One System approved by the FDA?

Implant-One System received FDA 510(k) clearance on 2023-08-15, under approval number K231455.

What company makes Implant-One System?

Implant-One System is manufactured by Implant Logistics, Inc..

What is the FDA product code for Implant-One System?

The FDA product code for Implant-One System is NHA.

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 Implant Logistics, Inc.

K173701Implant-One System K212394Implant-One Multi-Unit Abutment

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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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