Results for “Sterile Posterior Spinal Fixation System”

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Registry EUDAMED 648 FDA 510(k) incl. De Novo FDA PMA GUDID 107

Country / market European Union (all) 648 United States 107

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Germany 647 France 1

Risk class Class I Class IIa Class IIb 647 Class III 1 Class II (US) 107

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Sterile Posterior Spinal Fixation System

Shanghai Reach Medical Instrument Co., Ltd,China Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIb
MPM-U Spinal Posterior Fixation System, non-sterile

Eurospine SARL,France

Active Regimes: CE MDD Registry: EUDAMED Class:III

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Results for “Sterile Posterior Spinal Fixation System”

Category (EMDN)

Sterile Posterior Spinal Fixation System

MPM-U Spinal Posterior Fixation System, non-sterile