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FDA 510(k)

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K 號:K260546 · 2026-03-17

申請人K2m, Inc.
決定日期2026-03-17
產品代碼OLO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Q Pedicle Instruments is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K260546. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q Pedicle Instruments?

Q Pedicle Instruments is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is K2m, Inc.. The 510(k) number is K260546.

When did Q Pedicle Instruments receive FDA 510(k) clearance?

Q Pedicle Instruments received FDA 510(k) clearance on 2026-03-17, under 510(k) number K260546.

Who is the listed applicant for Q Pedicle Instruments?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Pedicle Instruments?

The FDA product code for Q Pedicle Instruments is OLO.

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其他以 K2m, Inc. 為申請人之記錄

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相關器械(代碼:OLO)

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官方來源

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