DE CONFORMIDADE BAUMER S.A. DIVISAO ORTOPEDIA. Av. Prefeito Antonio Tavares Leite, Parque da Empresa Magi Mirim - Sao Paulo - Brasil

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4 BAlJMER DECLARA~AO DECLARATON DE CONFORMDADE OF CONFORMTY A empresa: The company: BAUMER S.A. DVSAO ORTOPEDA Av. Prefeito Antonio Tavares Leite, Parque da Empresa Magi Mirim - Sao Paulo - Brasil Declara que, em sua (mica responsabilidade, 0 produto(s): Declares that, in its own responsability, the product(s): mplantes Ortopedicos Estereis e Nao-estereis Sterile and Non-Sterile Orthopaedic mplants Tipo: Vide relac;ao anexa no Certificado EC Type: See attached list in EC Certificate Produto Classe lb (Regra 8, Anexo X) Classb Product (Rule 8, Annex X) Declara que esse produto nao e fabricado utilizando-se tecido de origem animal. Declares that this product is not manufactured with tissues of animal origin. Declara que esse produto nao e e nem possui uma substancia medicinal em sua composic;ao. Declares that this product is not and does not include a medicinal substance in its composition. Declara que 0 Sistema de Gestao da Qualidade implementado atende a norma EN SO 13485:2003. Declares that the implemented Quality Management System is in accordance to EN SO 13485:2003. Vendas: 55 (11) Fax: 55 (11) w'nw.baume:.com.br baumer@baumer.combr Baumer SA Fabrica:Av. Pref.Antonio 1.Leite,181 Parqueda Empresa' Magi Mirim SP Tel: 55 (19) Fax:55 (19)

5 13AlJME.R Esta em conformidade com: Conforms to: Anexo da Diretiva de Dispositivos Medicos - 93j42jCEE Annex of Medical Devices Directive - 93/42/EEC Atraves do atendimento das seguintes Normas Tecnicas Harmonizadas e nternacionais: By compliment of the following nternational and Harmonized Technical Standards: Normas Gerais: General Standards: EN 980: Symbols for use in the labelling of medical devices; EN 1041: nformation supplied by the manufacturer of medical devices; EN SO : Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; EN SO : Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; EN SO : Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; EN SO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes; SOjTR 14283: mplants for surgery - Fundamental principles; EN SO 14630: Non-active surgical implants - General requirements; EN SO 14971: Medical devices - Application of risk management to medical devices; EN SO 16054: mplants for surgery - Minimum data sets for surgical implants; SO 8828: mplants for surgery -- Guidance on care and handling of orthopaedic implants; ASTM F Standard Practice for Surface Preparation and Marking of Metallic Surgical mplants; ASTM F565-04(2009)e1 - Standard Practice for Care and Handling of Orthopedic mplants and nstruments; ASTM F983-86(2005)e1 - Standard Practice for Permanent Marking of Orthopaedic mplant Components; ASTM F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Vendas: 55 (11) Fax: 55 (11) lv#w.b~.ume~.com.br bsumer@baumer.com.br Baumer SA Fabrica:Av. Pref.Antonio T. Leite,181 ParqLeda Empresa' Magi Mirim' SP Tel: 55(19) Fax:55 (19)

6 BAlJMER Normas para Materiais: Materials Standards: SO : mplants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel; SO 9583: mplants for surgery - Non-destructive testing -- Liquid penetrant inspection at metallic surgical implants; ASTM F Standard Specification for Unalloyed Titanium, for Surgical mplant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700); ASTM F136-08e1 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium EL (Extra Low nterstitial) Alloy for Surgical mplant Applications (UNS R56401); ASTM F Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical mplants (UNS S31673); ASTM F Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Sheet and Strip for Surgical mplants (UNS S31673); ASTM F601-03(2008) - Standard Practice for Fluorescent Penetrant nspection of Metallic Surgical mplants; ASTM Fl Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings; ASTM F Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical mplants; ASTM F Standard Test Method for Stereological Evaluation of Porous Coatings on Medical mplants; ASTM F (2007)e2 - Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser; ASTM F Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical mplant Applications. Normas para Osteosintese: Osteosynthesis Standards: EN SO 14602: Non-active surgical implants - mplants for osteosynthesis - Particular requirements; SO 5835: mplants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dimensions; SO 5836: mplants for surgery - Metal bone plates - Holes corresponding to screws with asymmetrical thread and spherical under-surface; SO : mplants for surgery - ntramedullary nailing systems - Part 1: ntramedullary nails with cloverleaf or V-shaped cross-section; SO : mplants for surgery - ntramedullary nailing systems - Part 2: Medullary pins; SO : mplants for surgery - Skeletal pins and wires - Part 1: Material and mechanical requirements; SO : mplants for surgery - Skeletal pins and wires - Part 2: Steinmann skeletal pins - Dimensions; SO : mplants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires; SO 6475: mplants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical requirements and test methods; Vendas: 55 (11) ' Fax: 55 (11) bsumec@baumer.combr Baumer S.A. Fabrica:Av. Pref.Antonio T. Leite,181 Parqooda Empresa' Magi Mirim' SP Tel: 55 (19) Fax:55(19)

7 BAJMER SO 8615: mplants for surgery - Fixation devices for use in the ends of the femur in adults; SO 8827: mplants for surgery - Staples with parallel legs for orthopaedic use - General requirements; SO 9585: mplants for surgery - Determination of bending strength and stiffness of b-one plates; SO 10334: mplants for surgery - Malleable wires for use as sutures and other surgical applications; SO : mplants for surgery - Metal intramedullary nailing systems - Part 1: ntramedullary nails; SO : mplants for surgery - Metal intramedullary nailing systems - Part 2: Locking components; SO : mplants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter measurements; ASTM F366-04(2009) - Standard Specification for Fixation Pins and Wires; ASTM F382-99(2008)e1 - Standard Specification and Test Method for Metallic Bone Plates; ASTM F384-06e1 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices; ASTM F543-07e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws; ASTM F564-02(2006) - Standard Specification and Test Methods for Metallic Bone Staples; ASTM F (2007)e2 - Standard Specification and Test Methods for ntramedullary Fixation Devices; ASTM F (2007)e1 - Standard Specification and Test Methods for External Skeletal Fixation Devices. Normas para Dispositivos de Coluna: Spinal Devices Standards: ASTM F (2003) - Standard Terminology Relating to Spinal mplants; ASTM F Standard Test Methods for Spinal mplant Constructs in a Vertebrectomy Model; ASTM F (2008) - Standard Guide for Evaluating the Static and Fatigue Properties of nterconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis mplants; ASTM F Test Methods For ntervertebral Body Fusion Devices; ASTM F (2007) - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System; ASTM F Standard Test Methods for Occipital-Cervical and Occipital- Cervical-Thoracic Spinal mplant Constructs in a Vertebrectomy Model. Representante Legal na Comunidade Europeia: Legal Representative in European Community: Gi Bi. S.a.s Di Bisegna Tatiana Via Rodolfo Lanciani, Tivoli - Roma - taly Vendas: 55 (11) 3670_0000 Fax: 55 (11) b8umec@baumcr.combr Baumer S.A. Fabrica:Av. Pre!.Antonio 1. Leite,181 Parqueda Empresa' Magi Mirim' SP Tel: 55 (19) Fax: 55 (19)

8 BAllMER Organismo de Certifica~ao: Notified Body: Certificado no: Certificate no: Magi Mirim - SP, Brasil, 6 de Julha de 2009 Mogi Mirim - SP/ Brazil, July, 6/ 2009 e> /~ Carlos 0~ ~-== Gallo Responsavel Tecnico Technical Responsible Vendas: 55 (11) ' Fax: 55 (11) '",'Ww.b~.Lim,"! combf bgumu@baul11er.combr Baumer SA Fabrica: Av. Pre!. Antonio T. Leite, 181 Parque da Empresa' Magi Mirim' SP Tel: 55 (19) Fax: 55 (19)