EsTemp Implant
K 號：K262983 · 2026-09-25
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器材摘要
EsTemp Implant is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262983. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EsTemp Implant?
EsTemp Implant is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Spident Co., Ltd.. The 510(k) number is K262983.
When did EsTemp Implant receive FDA 510(k) clearance?
EsTemp Implant received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262983.
Who is the listed applicant for EsTemp Implant?
The FDA 510(k) record lists Spident Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EsTemp Implant?
The FDA product code for EsTemp Implant is EMA.
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其他以 Spident Co., Ltd. 為申請人之記錄
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相關器械（代碼：EMA）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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