FDA 510(k)

Anthology 髋部釘；CPCS 髋部釘；股骨頭；R3 骨盆蓋內衬；Spectron 髋部釘；Synergy 髋部釘

K 號：K240783 · 2024-10-21

決定日期2024-10-21

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-10-21 under 510(k) number K240783. 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 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems is a medical device that received FDA 510(k) clearance on 2024-10-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240783.

When did Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems receive FDA 510(k) clearance?

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems received FDA 510(k) clearance on 2024-10-21, under 510(k) number K240783.

Who is the listed applicant for Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

FDA 510(k) 記錄將史密斯與內夫公司（Smith & Nephew, Inc.）列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

The FDA product code for Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems is JDI.

其他以 Smith & Nephew, 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。

K261462LANDMARK 全膝系統 K261968Q-FIX KNOTLESS 全縫線锚，2.8mm，附一條黑色無節縫線及一條藍色 MINITAPE 縫線（72205981）；Q-FIX KNOTLESS 全縫線锚，2.8mm，附一條藍色無節縫線及一條黑色 MINITAPE 縫線（72205982）K254084AETOS肩關節系統 - CONCELOC關節盤 K252416AETOS肩關節系統 Meta 肱骨假體尺寸 0 K252129AETOS肩關節系統無柄肱骨假體 K251627BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（雜綉藍）；BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（雜綉黑）；BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（白色）；BIORAPTOR CURVED 2.3 PK 緝合釘配ONE 38 ULTRABRAID (#2) 緝合線（雜綉黑）；BIORAPTOR CURVED 2.3 PK 緝合釘配ONE 38 ULTRABRAID (#2) 緝合線（雜綉藍）

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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。

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官方來源

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