FDA 510(k)

Smart SPACE Shoulder Planner and 3D Positioners

Número K: K222405 · 2022-12-20

Data da decisão2022-12-20

Código do produtoQHE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart SPACE Shoulder Planner and 3D Positioners is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K222405. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart SPACE Shoulder Planner and 3D Positioners?

Smart SPACE Shoulder Planner and 3D Positioners is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K222405.

When did Smart SPACE Shoulder Planner and 3D Positioners receive FDA 510(k) clearance?

Smart SPACE Shoulder Planner and 3D Positioners received FDA 510(k) clearance on 2022-12-20, under 510(k) number K222405.

Who is the listed applicant for Smart SPACE Shoulder Planner and 3D Positioners?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart SPACE Shoulder Planner and 3D Positioners?

The FDA product code for Smart SPACE Shoulder Planner and 3D Positioners is QHE.

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

Outros registros que listam Lima Corporate S.P.A. como candidato(a)

K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System K251718ArTT Aumenta e Apoia e Parafusos de Osso K243826SMR Reverse HP Shoulder System K250980Physica System (Physica CR Porous Femoral components)K243615Physica Porous Femoral Components K234011AMF TT Cones

Ver todos os 41 dispositivos →

Dispositivos Relacionados (Código: QHE)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Sistema PSI Archer3D-Side K241470CORE Shoulder SystemLinkBio Corp.

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.