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Manufacturer of surgical implants and medical devices based in Wervicq-Sud, France since 1848.
FranciaFundada en 1848Fabricante · SaludISO 13485MDR
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.
manual operator
Surgical technique manual for the IntraSPINE dynamic interlaminar stabilization system, detailing product features, surgical approaches (mini-invasive mono-lateral and midline bilateral), and a list of available implant sizes and required instrument sets.
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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.
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Instructions for use for the IntraSPINE interlaminar prosthesis, including indications, contraindications, MRI safety information, and cleaning/sterilization protocols for associated ancillaries and trial prostheses.
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Instructions for use for the NAJA ancillaries set, intended for the placement of the NAJA ligament system for spinal stabilisation. Includes detailed decontamination, cleaning, and sterilization procedures for reusable instruments.
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Instructions for use for the 4D DOME semi-resorbable parietal reinforcement implant, designed for the repair of inguinal and femoral hernias. Includes information on indications, contraindications, surgical precautions, and device handling.
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Instructions for use for the PREMIUM sterile extraperitoneal non-resorbable parietal reinforcement implant, covering product description, indications, surgical procedures for open and laparoscopic hernia repair, and safety precautions.
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Instructions for use for the IntraSPINE interspinous device, covering indications, contraindications, surgical precautions, MRI safety, and potential secondary effects.
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Instructions for use for the SACROMESH SOFT PROLAPSE urogenital implant, covering indications, surgical procedure, contraindications, and safety information for sacrocolpopexy.
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Instructions for use for the BIOMESH CA.B.S.'Air sterile extraperitoneal non-resorbable parietal reinforcement implant, detailing surgical procedures for inguinal and umbilical hernia repair.
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Instructions for use for the BIOMESH CA.B.S.'Air Composite, a sterile, non-resorbable parietal reinforcement implant for umbilical and ventral hernia repair. Includes details on product composition, surgical procedure, contraindications, and handling.
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Instructions for use for the BIORING adjustable gastric banding system, including device description, surgical technique, indications, contraindications, and safety information.
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Instructions for use for the BDyn sterile spinal dynamic posterior stabilization device, covering description, materials, indications, contraindications, side effects, precautions, and surgical technique.
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Instructions for use for the single-use NAJA and ResCUBE ancillary system, intended for the placement of spinal stabilization ligament systems. Includes information on materials, storage, precautions, and single-use warnings.
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Instructions for use for the ADHESIX BIORING adjustable gastric banding system, covering device description, composition, indications for morbid obesity, contraindications, surgical technique, and safety precautions.
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Instructions for use for the ADHESIX BIORING replacement kit, including components for gastric banding repair, surgical implantation guidelines, contraindications, and post-operative care.
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Instructions for use for the NAJA Ligament System, a spinal implant system for correction and stabilization of the spine. Includes descriptions of materials, indications, contraindications, MRI safety information, and surgical precautions.
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Instructions for use for the NAJA spinal implant system and single-use tensioner, covering indications, contraindications, MRI safety, and surgical precautions.
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Instructions for use for the ResCUBE spinal stabilization system, a temporary implant for orthopedic surgery including spinal trauma, reconstruction, and degenerative surgery. Includes details on materials, indications, contraindications, and surgical precautions.
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Instructions for use for the LIFT suburethral support tape, a non-resorbable polypropylene implant for treating feminine stress incontinence, including surgical technique, contraindications, and cleaning protocols for associated ancillaries.
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Instructions for use for the BIOMESH and C.A.B.S.'Air SR semi-resorbable parietal reinforcement implant, covering surgical procedure, indications, contraindications, and safety precautions for hernia repair.
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Instructions for use for the ACL Femoral Cortical Attachment, a sterile, single-use cortical fixation system for tendons and ligaments during ACL reconstruction. Includes surgical technique, material specifications, contraindications, and storage instructions.
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Instructions for use for the SOFT LIFT Kit, a sterile suburethral support tape system for the surgical treatment of female urinary incontinence, including details on surgical approach, materials, contraindications, and usage precautions.
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Surgical technique manual for the IntraSPINE dynamic interlamellar stabilization system, detailing product features, surgical approaches, and kit contents including sizing and ancillary instruments.