JULIET® LL Lateral Lumbar Cage
K 號：K161888 · 2016-09-12
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器材摘要
JULIET® LL Lateral Lumbar Cage is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2016-09-12 under 510(k) number K161888. 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 JULIET® LL Lateral Lumbar Cage?
JULIET® LL Lateral Lumbar Cage is a medical device that received FDA 510(k) clearance on 2016-09-12. The listed applicant is Spineart. The 510(k) number is K161888.
When did JULIET® LL Lateral Lumbar Cage receive FDA 510(k) clearance?
JULIET® LL Lateral Lumbar Cage received FDA 510(k) clearance on 2016-09-12, under 510(k) number K161888.
Who is the listed applicant for JULIET® LL Lateral Lumbar Cage?
The FDA 510(k) record lists Spineart as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for JULIET® LL Lateral Lumbar Cage?
The FDA product code for JULIET® LL Lateral Lumbar Cage is MAX.
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其他以 Spineart 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：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。
K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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