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FDA 510(k)

LL Implant System

K-Number: K242379 · 2024-11-07

Decision Date2024-11-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LL 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 2024-11-07 under 510(k) number K242379. 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 LL Implant System?

LL Implant System is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K242379.

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

LL Implant System received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242379.

Who is the listed applicant for LL 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 LL Implant System?

The FDA product code for LL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.