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FDA 510(k)

LW Narrow Implant System

K-Number: K233808 · 2024-07-31

Decision Date2024-07-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Narrow Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233808. 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 Narrow Implant System?

LW Narrow Implant System is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K233808.

When did LW Narrow Implant System receive FDA 510(k) clearance?

LW Narrow Implant System received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233808.

Who is the listed applicant for LW Narrow Implant System?

The FDA 510(k) record lists Ossvis Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LW Narrow Implant System?

The FDA product code for LW Narrow Implant System is DZE.

Other records listing Ossvis Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.