FDA 510(k)

OSSTM 骨科救護系統

K 號：K253434 · 2026-07-01

決定日期2026-07-01

產品代碼JDI

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決定相當於

器材摘要

OSSTM Orthopedic Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K253434. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSSTM Orthopedic Salvage System?

OSSTM Orthopedic Salvage System is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Biomet, Inc.. The 510(k) number is K253434.

When did OSSTM Orthopedic Salvage System receive FDA 510(k) clearance?

OSSTM Orthopedic Salvage System received FDA 510(k) clearance on 2026-07-01, under 510(k) number K253434.

Who is the listed applicant for OSSTM Orthopedic Salvage System?

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

What is the FDA product code for OSSTM Orthopedic Salvage System?

The FDA product code for OSSTM Orthopedic Salvage System is JDI.

其他以 Biomet, Inc. 為申請人之記錄

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相關器械（代碼：JDI）

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。

K253515Zimmer Biomet OSS™ 骨科救傷系統 OsseoTi® 穿孔套管及增強件Biomet Orthopedics, Inc.K252824Evolve AP杯，世界鳍杯，世界G-Zero Liner及奇數球頭Signature Orthopaedics Pty, Ltd.K243571trabecular金屬骨盆修復系統，骨盆內襯及限制性內襯Zimmer Biomet K240783Anthology 髋部釘；CPCS 髋部釘；股骨頭；R3 骨盆蓋內衬；Spectron 髋部釘；Synergy 髋部釘Smith & Nephew, Inc.K241716全球模組化更換系統，模組化更換系統，模組化旋轉軸承膝關節元件Howmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker 骨科髋關節系統標籤更新Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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