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OSARTIS GmbH

Last updated May 25, 2026

Information

Device	Model / Reference	Registries	Class	Status
ManuMix	02-0601	FDA UDI	Class I	Active
BonOs R Genta 1x40	01-0217	FDA UDI	Class II	Active
EASYMIX® Nozzle slim	02-0104	FDA UDI	Class I	Active
Simplex HV with Gentamicin	6195-1-001	FDA UDI	Class II	Active
BonOs Inject	01-0309	FDA UDI	Class II	Active
EASYMIX cement injector	02-0504-04	FDA UDI	Class I	Active
EASYMIX® vacuum pump II	02-0201	FDA UDI	Class I	Active
EASYMIX® Nozzle revision	02-0105	FDA UDI	Class I	Active
EASYMIX pro	02-0305	FDA UDI	Class I	Active
EASYMIX® compressed air hose	02-0205	FDA UDI	Class I	Active
Vertecem II Cement Kit	08.702.017S	FDA UDI	Class II	Active
BonOs HV Genta	1x40	FDA UDI	Class II	Active
Simplex HV	6194-1-001	FDA UDI	Class II	Active
BonOs HV	1x40	FDA UDI	Class II	Active
BonOs R 1x40	01-0117	FDA UDI	Class II	Active
EASYMIX® vacuum pump I	02-0401	FDA UDI	Class I	Active
EASYMIX® compressed air hose	02-0206	FDA UDI	Class I	Active
BonOs Inject, Pedicle screw kits, Cement pusher	K202458	FDA 510(k)	Class II	Active
Hi-Fatigue G Bone Cement	K192379	FDA 510(k)	Class II	Active
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds	K240856	FDA 510(k)	Class II	Active
BonOs HV, BonOs MV, BonOs LV	K210120	FDA 510(k)	Class II	Active
Hi-Fatigue Bone Cement	K192394	FDA 510(k)	Class II	Active
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta	K210125	FDA 510(k)	Class II	Active

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Establishments registered with the FDA under this company group, matched by name.