Results for “Constrained Knee Tibial Insert”

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Registry EUDAMED 149 FDA 510(k) incl. De Novo 1 FDA PMA GUDID

Country / market European Union (all) 149 United States 1

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Germany 149

Risk class Class I Class IIa Class IIb Class III 149 Class II (US) 1

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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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Constrained Knee Tibial Insert with Stem & extra PE Hex Bolt

Biotech GmbH,Germany Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:III
Constrained Knee Tibial Insert

Biotech GmbH,Germany Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:III

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Results for “Constrained Knee Tibial Insert”

Category (EMDN)

Constrained Knee Tibial Insert with Stem & extra PE Hex Bolt

Constrained Knee Tibial Insert