FDA 510(k)

SMR TT雙模組肩胛盂，SMR 3釘固定肩胛盂

K 號：K213785 · 2022-05-13

決定日期2022-05-13

產品代碼KWS

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決定相當於

器材摘要

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Limacorporate. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K213785. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Limacorporate. The 510(k) number is K213785.

When did SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid receive FDA 510(k) clearance?

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213785.

Who is the listed applicant for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

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

What is the FDA product code for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

The FDA product code for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is KWS.

其他以 Limacorporate 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。

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相關器械（代碼：KWS）

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。

K260721Tornier Perform 高級肩胛盂Tornier, Inc.K254084AETOS肩關節系統 - CONCELOC關節盤Smith & Nephew, Inc.K252418催化劑F1x肩部系統Catalyst Orthoscience, Inc.K252416AETOS肩關節系統 Meta 肱骨假體尺寸 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier肩胛骨重建系統（Tornier HRS）；Tornier Perform肩胛骨系統 - 植骨（Tornier PHS-Stem）Stryker Corporation (Tornier, Inc.)

官方來源

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