FDA 510(k)

PERLA® TL 系統；TEKTONA® HV US 骨水泥

K 號：K230774 · 2023-06-23

決定日期2023-06-23

產品代碼PML

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決定相當於

器材摘要

PERLA® TL System; TEKTONA® HV US Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230774. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PERLA® TL System; TEKTONA® HV US Bone Cement?

PERLA® TL System; TEKTONA® HV US Bone Cement is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Spineart. The 510(k) number is K230774.

When did PERLA® TL System; TEKTONA® HV US Bone Cement receive FDA 510(k) clearance?

PERLA® TL System; TEKTONA® HV US Bone Cement received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230774.

Who is the listed applicant for PERLA® TL System; TEKTONA® HV US Bone Cement?

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 PERLA® TL System; TEKTONA® HV US Bone Cement?

The FDA product code for PERLA® TL System; TEKTONA® HV US Bone Cement is PML.

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。

K213470PERLA® TL 後方骨板固定系統 K210472脊椎藝術導航儀器系統 K203506PERLA® TL後方骨板固定系統 K203222PERLA TL 後方骨板固定系統 K200571PERLA® 頸胸椎後固定系統 K200312Tryptik Ti

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相關器械（代碼：PML）

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。

K260286Dynamo™脊椎水泥；Salvo®脊椎系統Spine Wave, Inc.K252885奧林匹克後脊椎固定系統；馬薩達模組化脊椎固定系統Astura Medical K241034Meta+ 骨水泥 & M.U.S.T. 穿孔椎板螺釘系統Medacta International S.A.K231809Momentum® 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥；Momentum® MIS 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥Ulrich Medical USA K222789VADER®脊椎系統，G21水泥Icotec AG K221926Invictus®骨水泥，Invictus脊椎固定系統Alphatec Spine, Inc.

官方來源

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