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FDA 510(k)

LW Implant System – Abutment

K-Number: K233167 · 2024-03-25

ApplicantOssvis Co., Ltd.
Decision Date2024-03-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Implant System – Abutment is a medical device manufactured by Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2024-03-25 under approval number K233167. 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 LW Implant System – Abutment?

LW Implant System – Abutment is a medical device that received FDA 510(k) clearance on 2024-03-25. It is manufactured by Ossvis Co., Ltd.. The 510(k) number is K233167.

When was LW Implant System – Abutment approved by the FDA?

LW Implant System – Abutment received FDA 510(k) clearance on 2024-03-25, under approval number K233167.

What company makes LW Implant System – Abutment?

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

What is the FDA product code for LW Implant System – Abutment?

The FDA product code for LW Implant System – Abutment is NHA.

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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 K223924LW Implant System K242703LW Pre-milled Abutment K242379LL Implant System K233808LW Narrow Implant System

View all 7 devices →

Related Devices (Code: NHA)

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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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