K5 Cart, K5 Mount, K5 Swing
K-Number: K251491 · 2025-07-17
Decision Date2025-07-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
K5 Cart, K5 Mount, K5 Swing is a medical device manufactured by Osstem Implant Company., Ltd. Chair Business. It received FDA 510(k) clearance on 2025-07-17 under approval 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. It is manufactured by Osstem Implant Company., Ltd. Chair Business. The 510(k) number is K251491.
When was K5 Cart, K5 Mount, K5 Swing approved by the FDA?
K5 Cart, K5 Mount, K5 Swing received FDA 510(k) clearance on 2025-07-17, under approval number K251491.
What company makes K5 Cart, K5 Mount, K5 Swing?
K5 Cart, K5 Mount, K5 Swing is manufactured by Osstem Implant Company., Ltd. Chair Business.
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.
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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.