FDA 510(k)

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK 金屬網格

K 號：K212038 · 2021-08-27

決定日期2021-08-27

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is the device name listed in this FDA 510(k) record. The listed applicant is K&J Consulting Corporation. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K212038. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is K&J Consulting Corporation. The 510(k) number is K212038.

When did K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage receive FDA 510(k) clearance?

K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212038.

Who is the listed applicant for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

The FDA 510(k) record lists K&J Consulting Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage?

The FDA product code for K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage is ODP.

其他以 K&J Consulting Corporation 為申請人之記錄

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相關器械（代碼：ODP）

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。

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