FDA 510(k)

Testa TP 旋轉間隔系統

K 號：K243816 · 2025-06-27

決定日期2025-06-27

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Testa TP Pivoting Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243816. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Testa TP Pivoting Spacer System?

Testa TP Pivoting Spacer System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Spine Wave, Inc.. The 510(k) number is K243816.

When did Testa TP Pivoting Spacer System receive FDA 510(k) clearance?

Testa TP Pivoting Spacer System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243816.

Who is the listed applicant for Testa TP Pivoting Spacer System?

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

What is the FDA product code for Testa TP Pivoting Spacer System?

The FDA product code for Testa TP Pivoting Spacer System is MAX.

其他以 Spine Wave, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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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