FDA 510(k)

BonOs® 注射骨水泥；NEO 椎板螺釘系統™

K 號：K222256 · 2022-08-26

決定日期2022-08-26

產品代碼PML

諮詢委員會或

決定相當於

器材摘要

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K222256. 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 BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Neo Medical SA. The 510(k) number is K222256.

When did BonOs® Inject Bone Cement; NEO Pedicle Screw System™ receive FDA 510(k) clearance?

BonOs® Inject Bone Cement; NEO Pedicle Screw System™ received FDA 510(k) clearance on 2022-08-26, under 510(k) number K222256.

Who is the listed applicant for BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

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

What is the FDA product code for BonOs® Inject Bone Cement; NEO Pedicle Screw System™?

The FDA product code for BonOs® Inject Bone Cement; NEO Pedicle Screw System™ is PML.

其他以 Neo Medical SA 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。

K243693NEO椎板螺釘系統™K212489BonOs 注射骨水泥；NEO 椎板螺釘系統 K191796Neo籠架系統 K181048Neo Cage System 商標 K171582NEO椎板螺釘系統™

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 K230774PERLA® TL 系統；TEKTONA® HV US 骨水泥Spineart K222789VADER®脊椎系統，G21水泥Icotec AG

官方來源

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