FDA 510(k)

TECHFIT Patient-Specific Cranial System

Número K: K250297 · 2025-10-27

Data da decisão2025-10-27

Código do produtoGWO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TECHFIT Patient-Specific Cranial System is the device name listed in this FDA 510(k) record. The listed applicant is Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K250297. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TECHFIT Patient-Specific Cranial System?

TECHFIT Patient-Specific Cranial System is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K250297.

When did TECHFIT Patient-Specific Cranial System receive FDA 510(k) clearance?

TECHFIT Patient-Specific Cranial System received FDA 510(k) clearance on 2025-10-27, under 510(k) number K250297.

Who is the listed applicant for TECHFIT Patient-Specific Cranial System?

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

What is the FDA product code for TECHFIT Patient-Specific Cranial System?

The FDA product code for TECHFIT Patient-Specific Cranial System is GWO.

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 Techfit Digital Surgery, Inc. como candidato(a)

K242263TECHFIT DISRP® System K222577TECHFIT Diagnostic Models K220199Sistema Proximal Tibia AFFINITY

Dispositivos Relacionados (Código: GWO)

K262874CraniUS PlateCraniUS, LLC K261058CraniUS PlateCraniUS, LLC K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391Sistema de Fixação Neurológica MCI-NeuroMci Medical Concept Innovation, Inc.K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)Osteonic Co., Ltd.

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.