FDA 510(k)

Invictus® Bone Cement, Invictus Spinal Fixation System

Número K: K221926 · 2022-12-20

Data da decisão2022-12-20

Código do produtoPML

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Invictus® Bone Cement, Invictus Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K221926. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Invictus® Bone Cement, Invictus Spinal Fixation System?

Invictus® Bone Cement, Invictus Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K221926.

When did Invictus® Bone Cement, Invictus Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Bone Cement, Invictus Spinal Fixation System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221926.

Who is the listed applicant for Invictus® Bone Cement, Invictus Spinal Fixation System?

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

What is the FDA product code for Invictus® Bone Cement, Invictus Spinal Fixation System?

The FDA product code for Invictus® Bone Cement, Invictus Spinal Fixation System is PML.

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 Alphatec Spine, Inc. como candidato(a)

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System K253216IntraOp Alignment System; CONTOUR3D Bending System K253615Invictus Bands System K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix System K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

Ver todos os 61 dispositivos →

Dispositivos Relacionados (Código: PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG

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.