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FDA 510(k)

K5 Cart, K5 Mount, K5 Swing

K-Number: K251491 · 2025-07-17

ApplicantOsstem Implant Company., Ltd. Chair Business
Decision Date2025-07-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K5 Cart, K5 Mount, K5 Swing is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Company., Ltd. Chair Business. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K251491. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K5 Cart, K5 Mount, K5 Swing?

K5 Cart, K5 Mount, K5 Swing is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Osstem Implant Company., Ltd. Chair Business. The 510(k) number is K251491.

When did K5 Cart, K5 Mount, K5 Swing receive FDA 510(k) clearance?

K5 Cart, K5 Mount, K5 Swing received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251491.

Who is the listed applicant for K5 Cart, K5 Mount, K5 Swing?

The FDA 510(k) record lists Osstem Implant Company., Ltd. Chair Business as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K5 Cart, K5 Mount, K5 Swing?

The FDA product code for K5 Cart, K5 Mount, K5 Swing is EIA.

Related Devices (Code: EIA)

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.

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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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