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FDA 510(k)

LW Implant System

K-Number: K223924 · 2023-08-08

ApplicantOssvis Co., Ltd.
Decision Date2023-08-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Implant System is a medical device manufactured by Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2023-08-08 under approval number K223924. 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 LW Implant System?

LW Implant System is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Ossvis Co., Ltd.. The 510(k) number is K223924.

When was LW Implant System approved by the FDA?

LW Implant System received FDA 510(k) clearance on 2023-08-08, under approval number K223924.

What company makes LW Implant System?

LW Implant System is manufactured by Ossvis Co., Ltd..

What is the FDA product code for LW Implant System?

The FDA product code for LW Implant System is DZE.

Related Clinical Trials

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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 Ossvis Co., Ltd.

K231235LW UCLA Abutment K231079LW Retraction Cap K242703LW Pre-milled Abutment K242379LL Implant System K233808LW Narrow Implant System K233167LW Implant System – Abutment

View all 7 devices →

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.

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