Número da Revisão
Rev.03
Data de Expiração
14/06/2026
Descrição
Scope: "Design and Development, Manufacturing, Sales, Distribution of:
•Non-sterile implants: For osteotomy and traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class III
•Non-sterile Reusable Surgical Instruments: For surgical support in osteotomy, traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class I and Class II
• Sterile Surgical Instruments (ETO) with Disposable Coatings: For Cranio-Maxillofacial, Upper and Lower Limbs coated in Diamond and/or DLC; Cranio-Maxillofacial; For Traumatology, Arthroplasty and Maxillofacial coated in DLC Black or Diamond. – Class II
•Sterile Surgical Instruments (ETO): For surgical support in osteotomy, traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class II
•Disposable Temporomandibular Joint (ETO); - Class II
•Sterile implants (ETO) with applicator (disposable) with wire and anchor for soft tissue reconstruction; - Class III
•Sterile implants (ETO) with disposable applicator Button, Wire and Plate for fixation of fragments in syndesmotic fractures. – Class III
•Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of the anterior cruciate ligament (ACL). - Class III
•Sterile prostheses (ETO) for partial elbow arthroplasty; - Class IV •Sterile implants (ETO) for fixation of various bone fractures. - Class III"
•Non-sterile implants: For osteotomy and traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class III
•Non-sterile Reusable Surgical Instruments: For surgical support in osteotomy, traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class I and Class II
• Sterile Surgical Instruments (ETO) with Disposable Coatings: For Cranio-Maxillofacial, Upper and Lower Limbs coated in Diamond and/or DLC; Cranio-Maxillofacial; For Traumatology, Arthroplasty and Maxillofacial coated in DLC Black or Diamond. – Class II
•Sterile Surgical Instruments (ETO): For surgical support in osteotomy, traumatology (upper and lower limbs) and Cranio-Maxillofacial. – Class II
•Disposable Temporomandibular Joint (ETO); - Class II
•Sterile implants (ETO) with applicator (disposable) with wire and anchor for soft tissue reconstruction; - Class III
•Sterile implants (ETO) with disposable applicator Button, Wire and Plate for fixation of fragments in syndesmotic fractures. – Class III
•Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of the anterior cruciate ligament (ACL). - Class III
•Sterile prostheses (ETO) for partial elbow arthroplasty; - Class IV •Sterile implants (ETO) for fixation of various bone fractures. - Class III"
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Status
Ativo