FDA 510(k)

脊椎AR SNAP（同步AR脊椎）

K 號：K252054 · 2025-09-29

決定日期2025-09-29

產品代碼SBF

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

SpineAR SNAP (SyncAR Spine) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, Inc.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K252054. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpineAR SNAP (SyncAR Spine)?

SpineAR SNAP (SyncAR Spine) is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Surgical Theater, Inc.. The 510(k) number is K252054.

When did SpineAR SNAP (SyncAR Spine) receive FDA 510(k) clearance?

SpineAR SNAP (SyncAR Spine) received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252054.

Who is the listed applicant for SpineAR SNAP (SyncAR Spine)?

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

What is the FDA product code for SpineAR SNAP (SyncAR Spine)?

The FDA product code for SpineAR SNAP (SyncAR Spine) is SBF.

其他以 Surgical Theater, Inc. 為申請人之記錄

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。

K243623脊椎AR SNAP（同步AR脊椎）K213034脊椎AR快接 K201465蘇格術計劃員（SRP）腦暴風

相關器械（代碼：SBF）

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。

K261854xvision脊椎系統Augmedics, Ltd.K253805膝+Pixee Medical S.A.S.K252847NextAR 髋關節平台Medacta International S.A.K251639xvision脊椎系統Augmedics, Ltd.K252530OptiVu™ 肩部Mr Surgical Solutions, LLC K251737NextAR™ 肩部平台Medacta International S.A.

官方來源

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