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Results for “SpaceFlex Knee”

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Registry EUDAMED 4 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 4

Country / market European Union (all) 4 United States 5

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Italy 3 Netherlands 1

Risk class Class I 5 Class IIa Class IIb Class III 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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6 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

SpaceFlex Knee

G-21 S.R.L.,Italy Group of variants

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I
SpaceFlex Knee Trial 900201

G21 SRL,FDA registration: United States

None Registry: GUDID Class:I
SpaceFlex Knee - 80mm Size

G21 S.R.L.,Italy

Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II
SpaceFlex Knee

G21 S.R.L.,Italy

Active Regimes: CE MDD Registry: EUDAMED Class:I

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