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Data / Medical devices / Germany / Osartis GMBH

Osartis GMBH: FDA-registered device maker in Muenster Hesse, Germany, 11 510(k) clearances

Osartis GMBH is registered with the FDA (registration 9615014) in Muenster Hesse, Germany. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 20, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Osartis GMBH
FDA registration number
9615014
FEI number
3005568854
Address
Auf der Beune 101, Muenster Hesse, Germany, 64839
Owner or operator
OSARTIS GmbH (10055041)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
May 29, 2017
Registered through
2027
Brand names listed
BIOWASH Surgical Irrigation, BLASTX Wound Gel, Bactisure, BonOs HV, BonOs HV Genta, BonOs Inject, BonOs R, BonOs R Genta and more

Devices it lists

DeviceProduct codeClassRoleSource
Bone CementLOD2Contract manufacturer, Manufactureraccessdata.fda.gov
Bone Cement, AntibioticMBB2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Manufactureraccessdata.fda.gov
Dispenser, CementKIH1Manufactureraccessdata.fda.gov
Dressing, Wound, DrugFROUSpecification developeraccessdata.fda.gov
Evacuator, Vapor, Cement MonomerJDY1Manufactureraccessdata.fda.gov
Lavage, JetFQH2Specification developeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Specification developeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Specification developeraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Specification developeraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Specification developeraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Specification developeraccessdata.fda.gov
TemplateHWT1Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 20, 2024K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsMBBSubstantially EquivalentOsartis GmbHaccessdata.fda.gov
May 18, 2021K202458BonOs Inject, Pedicle screw kits, Cement pusherLODSubstantially EquivalentOsartis GmbHaccessdata.fda.gov
April 23, 2021K203835MIS SolutionFROSubstantially EquivalentNext Science, LLCaccessdata.fda.gov
March 19, 2021K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLODSubstantially EquivalentOsartis GmbHaccessdata.fda.gov
March 19, 2021K210120BonOs HV, BonOs MV, BonOs LVLODSubstantially EquivalentOsartis GmbHaccessdata.fda.gov
January 23, 2020K192349Bactisure Wound LavageFQHSubstantially EquivalentNext Science, LLCaccessdata.fda.gov
March 6, 2017K163188Next Science Wound Gel (Rx)FROSubstantially EquivalentNext Science, LLCaccessdata.fda.gov
March 15, 2013K123225BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60LODSubstantially EquivalentAap Biomaterials GmbH & Co. KGaccessdata.fda.gov
March 7, 2013K123081BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40LODSubstantially EquivalentAap Biomaterials GmbH & Co. KGaccessdata.fda.gov
October 19, 2012K121876VERTECEM II CEMENT KITNDNSubstantially EquivalentAap Biomaterials GmbHaccessdata.fda.gov
April 14, 2009K090460BONOS INJECTNDNSubstantially EquivalentAap Biomaterials GmbHaccessdata.fda.gov

Compare with other makers

Updated November 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.