SISTEMA DE IMPLANTES S4 AESCULAP
Nome do produto
SISTEMA DE IMPLANTES S4 AESCULAP
Número de registro
80136990476
Nome técnico
Classe de risco
IV
Processo
25351008973200551
Razão social
Fabricante
País de fabricação
ALEMANHA
Apresentações / Modelos(938)
ST107T.Parafuso Ósseo S4 Element Monoaxial: ST340T
ST139T.Parafuso de Augmentação Estéril: SW510TS
SW379T.Parafuso Ósseo Canulado Monoaxial – SW421T
SW479THastes Pré-Angulada – SW554T
SW493TConectores Transversais Ajustável – SW488T
SW498TParafuso Ósseo S4 Element Poliaxial: ST240T
SW567THastes Retas – SW573T
SW649TS.Conectores Não estéreis: SW838T
SW672TConectores Transversais Retos – SW690T
SW684THastes Retas – SW674T
SW696TConectores Transversais Ajustável – SW697T
SW749T.Parafuso Ósseo Transpedicular Poliaxial – SW751T
SW790TPinos de Armazenamento para Parafusos Monoaxiais – TE864P
SW799THastes Pré-Angulada – SW653T
TE858PParafuso Ósseo Canulado Poliaxial – SW321T
TE868PPinos de Armazenamento para Parafusos Poliaxiais – TE854P
Conectores Transversais Retos - SW690T
Ganchos – SW826T
Hastes Pré-Angulada - SW653T
Hastes Retas - SW674T
Parafuso de Augmentação S4 Element: ST422T
Parafuso de Retenção - SW687T
Parafuso de Retenção - SW790T
Parafuso de Retenção – SW687T
Parafuso Ósseo Canulado Monoaxial – SW421T
Parafuso Ósseo Canulado Poliaxial – SW321T
Parafuso Ósseo S4 Element Poliaxial: ST240T
Parafuso Ósseo Transpedicular Poliaxial - SW751T
Parafuso Óssseo Transpedicular Axial - SW701T
Parafuso Óssseo Transpedicular Axial - SW701T
Pinos de Armazenamento para Parafusos Monoaxiais - TE864P
Pinos de Armazenamento para Parafusos Poliaxiais - TE854P
Produto Não estéril
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SW591T, SW592T Ganchos – SW826T
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SW837T Parafuso de Retenção – SW375T Conectores Transversais Retos – SW490T
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SW872T, SW873T, SW874T, SW876T. Conectores Estéreis: SW838TS
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TE855P
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Instruções de Uso e Arquivos(2)
| Código | Tipo | Arquivo | Expedição | Expediente |
|---|---|---|---|---|
| T34317604 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | IU_Sistema de Implantes S4 Aesculap-Comp Estéreis.PDF | 29/11/2025, 00:40 | 1545593256 |
| T34317603 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | IU_Sistema de Implantes S4 Aesculap-Comp Não Estéreis.PDF | 29/11/2025, 00:40 | 1545593256 |
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
A atualização destes documentos é executada pela empresa responsável pela regularização do produto.
Documentos Técnicos(9)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 0929416183 | 26/12/2018 | MATERIAL – Alteração do prazo de validade em registro de material implantável em ortopedia | Publicado deferimento |
| 737921118 | 28/11/2011 | MATERIAL - Retificação – Correção pela ANVISA | Publicado deferimento |
| 063546104 | 19/10/2015 | MATERIAL - Revalidação de Registro de SISTEMA | Aditado ao processo |
| 439819050 | 17/10/2005 | MATERIAL - Retificação – Correção pela ANVISA | Publicado deferimento |
| 522888103 | 22/08/2011 | MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico | Publicado deferimento |
| 219201112 | 02/05/2011 | MATERIAL - Retificação – Correção pela ANVISA | Publicado deferimento |
| 506388084 | 19/04/2010 | MATERIAL - Alteração/Inclusão/Exclusão de apresentação comercial em registro. | Publicado indeferimento |
| 471294103 | 25/02/2011 | MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico | Publicado deferimento |
| 1040918141 | 26/01/2015 | MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico | Publicado deferimento |
MATERIAL – Alteração do prazo de validade em registro de material implantável em ortopedia
Publicado deferimento
MATERIAL - Retificação – Correção pela ANVISA
Publicado deferimento
MATERIAL - Revalidação de Registro de SISTEMA
Aditado ao processo
MATERIAL - Retificação – Correção pela ANVISA
Publicado deferimento
MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico
Publicado deferimento
MATERIAL - Retificação – Correção pela ANVISA
Publicado deferimento
MATERIAL - Alteração/Inclusão/Exclusão de apresentação comercial em registro.
Publicado indeferimento
MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico
Publicado deferimento
MATERIAL - Alteração/Inclusão/Exclusão de componente/acessório em Registro de sistema de material de uso médico
Publicado deferimento
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- ACETÁBULOS FEMORAIS PE CUP PARA ARTROPLASTIA DE QUADRIL80136990674
- AGULHA DE VERESS DESCARTÁVEL AESCULAP80136999019
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