FDA 510(k)

骨心脊椎內視鏡系統螺釘固定器系統

K 號：K221332 · 2022-07-28

決定日期2022-07-28

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

OsteoCentric Spine MIS Pedicle Fastener System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K221332. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoCentric Spine MIS Pedicle Fastener System?

OsteoCentric Spine MIS Pedicle Fastener System is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is OsteoCentric Technologies. The 510(k) number is K221332.

When did OsteoCentric Spine MIS Pedicle Fastener System receive FDA 510(k) clearance?

OsteoCentric Spine MIS Pedicle Fastener System received FDA 510(k) clearance on 2022-07-28, under 510(k) number K221332.

Who is the listed applicant for OsteoCentric Spine MIS Pedicle Fastener System?

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

What is the FDA product code for OsteoCentric Spine MIS Pedicle Fastener System?

The FDA product code for OsteoCentric Spine MIS Pedicle Fastener System is NKB.

其他以 OsteoCentric Technologies 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。

K251913OsteoCentric® UnifiMI® TCS 鋼板系統 K250494OsteoCentric 骨板及螺釘系統 K242691OsteoCentric Technologies 穿刺螺釘及螺母 K230242骨心齒植體系統 K230226Integrity-SI® 結合系統 K230595骨心臟前交叉韁綁固定系統

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相關器械（代碼：NKB）

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix Medical K262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.O K260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

官方來源

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