FDA 510(k)

LUMIS 穿通椎体釘固定システム、U.L.I.S. 椎体釘固定システム

K番号: K160124 · 2016-04-04

決定日2016-04-04

製品コードMNI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spinevision S.A.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K160124. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Spinevision S.A.. The 510(k) number is K160124.

When did LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System receive FDA 510(k) clearance?

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System received FDA 510(k) clearance on 2016-04-04, under 510(k) number K160124.

Who is the listed applicant for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

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

What is the FDA product code for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

The FDA product code for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is MNI.

申請者としてSpinevision S.A.を記載するその他の記録

K153783SpaceVision® PLIF、SpaceVision® OLIF、SpaceVision® TLIF

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