FDA 510(k)

Osteo3 ZP Putty

Número K: K193075 · 2020-06-09

Data da decisão2020-06-09

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Osteo3 ZP Putty is the device name listed in this FDA 510(k) record. The listed applicant is Sirakoss , Ltd.. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K193075. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Osteo3 ZP Putty?

Osteo3 ZP Putty is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Sirakoss , Ltd.. The 510(k) number is K193075.

When did Osteo3 ZP Putty receive FDA 510(k) clearance?

Osteo3 ZP Putty received FDA 510(k) clearance on 2020-06-09, under 510(k) number K193075.

Who is the listed applicant for Osteo3 ZP Putty?

The FDA 510(k) record lists Sirakoss , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteo3 ZP Putty?

The FDA product code for Osteo3 ZP Putty is MQV.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: MQV)

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AG K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker Spine K253524Adaptos® Grafto ósseoBiomendex OY K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.