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Manufacturer of surgical implants and medical devices based in Wervicq-Sud, France since 1848.
FranciaFundada en 1848Fabricante · SaludISO 13485MDR
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Instructions for use for the BDyn sterile spinal dynamic posterior stabilization device, intended for skeletal mature adults to restore spine segment stabilization from T10 to S1. Includes indications, contraindications, MRI safety information, and material composition.
clinical evaluation
This document is the Summary of Safety and Clinical Performance (SSCP) for the BDYN sterile spinal dynamic posterior stabilization devices, providing detailed clinical evaluation data, intended purpose, device description, and risk management information for both healthcare professionals and patients.
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Instructions for use for the ACL Femoral Cortical Attachment, a sterile, single-use cortical fixation system intended for anchoring tendons and ligaments during ACL reconstruction. Includes indications, contraindications, MRI safety information, and surgical precautions.
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Instructions for use for the 4DDOME semi-resorbable parietal reinforcement implant, covering indications, contraindications, surgical technique, and patient safety information for inguinal and femoral hernia repair.
clinical evaluation
This document is a Summary of Safety and Clinical Performance (SSCP) for sterile semi-resorbable parietal reinforcement implants, providing detailed clinical evaluation data, intended use, device description, and risk management information for both healthcare professionals and patients.
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Instructions for use for 4DFIX semi-resorbable parietal reinforcement implants, designed for the repair and reinforcement of inguinal and femoral hernias. Includes surgical technique, contraindications, and patient information.
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Instructions for use for the BIORING adjustable gastric band, a sterile, single-use implantable device for the treatment of morbid obesity. Includes details on device composition, indications, contraindications, surgical precautions, and explantation protocols.
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Instructions for use for the BIOMESH CA.B.S.'AIR COMPOSITE, a sterile, non-resorbable parietal reinforcement implant for ventral, umbilical, and incisional hernia repair. Includes surgical technique, contraindications, and patient information.
clinical evaluation
Summary of Safety and Clinical Performance (SSCP) for sterile intraperitoneal non-resorbable parietal reinforcement implants, detailing clinical data, safety, and performance evaluations.
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Instructions for use for INTRAMESH T1 sterile intraperitoneal non-resorbable parietal reinforcement implants, covering indications, contraindications, surgical technique, and safety information for hernia repair.
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Instructions for use for 4DMESH semi-resorbable parietal reinforcement implants, covering indications for inguinal and femoral hernia repair, contraindications, surgical precautions, and patient information requirements.
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Instructions for use for the Extended Plate for Cortical Fixation System, a sterile, single-use implant used for ACL reconstruction to anchor tendons and ligaments. Includes indications, contraindications, MRI safety information, and surgical precautions.
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Instructions for use for the Adjustable ACL Cortical Attachment, a sterile, single-use cortical fixation device intended for anchoring tendons and ligaments during ACL reconstruction. Includes indications, contraindications, MRI safety information, and surgical precautions.
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Instructions for use for the Sterile Self-Locking Polymer Cerclage System, covering indications, contraindications, surgical precautions, and MRI safety information.
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Instructions for use for BIOMESH P1 sterile extraperitoneal non-resorbable parietal reinforcement implants, covering indications, contraindications, surgical precautions, and explantation procedures.
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Instructions for use for 4DMESH semi-resorbable parietal reinforcement implants, covering indications for inguinal and femoral hernia repair, surgical procedure details, contraindications, and safety information.
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Instructions for use for the LIFT Kit, a sterile suburethral support tape system for the surgical treatment of urinary incontinence in women. Includes details on components, surgical approach, contraindications, and safety precautions.
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Instructions for use for 4D Ventral extraperitoneal partially resorbable parietal reinforcement implants, covering indications, contraindications, surgical procedure, and safety precautions.
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Instructions for use for the BIOMESH A2 and A4 sterile extraperitoneal non-resorbable parietal reinforcement implants, covering indications, contraindications, surgical precautions, and explantation procedures.
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Instructions for use for BIOMESH neurological patches (N3, N3L), which are non-resorbable, non-woven polyester meshes with a silicone coating, intended for cranial and spinal dura mater replacement and reinforcement.
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Instructions for use for the SOFT LIFT sterile urogenital implant, a suburethral support tape for treating feminine stress incontinence, including surgical procedure, cleaning instructions for associated ancillaries, and safety warnings.
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Instructions for use for the IntraSPINE interspinous prosthesis, a sterile, single-use device for interlaminar support in skeletally mature patients. Includes indications, contraindications, side effects, material composition, and MRI safety information.
clinical evaluation
Summary of Safety and Clinical Performance (SSCP) for the IntraSPINE device, providing detailed information on device identification, intended use, description, principles of operation, and safety risks for healthcare professionals.
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Instructions for use for INTRAMESH T1, a sterile, non-resorbable parietal reinforcement implant designed for umbilical and ventral hernia repair in laparoscopic or open surgery.