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510(k) Data Aggregation

    K Number
    K151708
    Device Name
    RECON system - Compression Screws
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2016-03-02

    (252 days)

    Product Code
    HWC, DEV, HTN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions. The RECON system consists of various system components and it is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
    Device Description
    The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws: - Microcan 1.8/2.3 ● - . Maxican 4.5 - CBS Micro Compression ● - CBS High Compression - CBS 4.5/7.5 ● - V-TEK Micro 2.0 ● - V-TEK Standard 3.0 ● screws of different sizes and designs. The screws and washers are made of titanium alloy Ti-6AI-4V (ASTM F136). The implants are offered in various sizes to accommodate the variations of bone size and geometry as well as plate sizes and configurations. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
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    K Number
    K151701
    Device Name
    Tenodesis screw system
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2016-01-26

    (216 days)

    Product Code
    HWC, MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery. The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
    Device Description
    The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors. The implants are offered in various sizes. The implants are provided non-sterile and single-use only. The Tenodesis instruments are non-sterile and reusable.
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    K Number
    K152256
    Device Name
    RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2015-11-05

    (87 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions. The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques. Gruber Lapidus The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity. Plantar Lapidus The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis. Tarsalis The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.
    Device Description
    The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws: - Gruber Lapidus Plates 2.7, . - . Plantar Lapidus Plates 2.7, - Tarsalis Plates 2.7, ● - Locking Screws 2.7 ● - Standard Screws 2.7 - Minican Screws 2.7/3.5 of different sizes and designs. The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67). The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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    K Number
    K152312
    Device Name
    RECON system-V-TEK-IVP Plates and Screws
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2015-10-30

    (74 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions. The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.
    Device Description
    The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws: - V-TEK™ IVP Micro XS Plate 2.7, ● - V-TEK™ IVP S Plate 2.7, . - V-TEK™ IVP S. L-Plate 2.7 . - . V-TEK™ IVP M Plate 2.7 - V-TEK™ IVP M Plate 3.5 . - . V-TEK™ IVP L Plate 2.7 - V-TEK™ IVP L Plate 2.7 / 3.5 - . Titanium Screw Fully Treaded 2.7/3.5 of different sizes and designs. The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136). The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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    K Number
    K152142
    Device Name
    RECON system - MPJ-Plates
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2015-09-16

    (44 days)

    Product Code
    HRS, DEV
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions. The RECON system – MPJ Plates consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used for adult patients. Additional information is provided in the corresponding surgical techniques. MP-Joint Fusion Plates 2.7 The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint. - Plate size S is indicated for standard MP-Joint fusions. - . Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes). Universal Reconstruction Plates 2.7 The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot. docPrice Revision Plates 2.7/3.5 The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.
    Device Description
    The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates: - MP - Joint Fusion Plates 2.7, - . Universal Reconstructions Plates 2.7, - . docPrice Revision Plates 2.7/3.5 of different sizes and designs. The plates are either made of titanium alloy Ti-6Al-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67). The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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    K Number
    K151407
    Device Name
    RECON system
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2015-08-12

    (78 days)

    Product Code
    HRS, HTN, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions. The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
    Device Description
    The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates: - Reconstruction Plates 3.5, ● - Medialis Plates 3.5, ● - Universal Plates 3.5 - Universal Plates 3.5, H-shaped . - USG Plates 3.5 ● - Interpositioning Arthrodesis Plates ● - Lapidus Plates ● - . Dwyer Plates screws and washers of different sizes and designs. The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67). The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
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    K Number
    K133035
    Device Name
    NORMED PELLEGRIN CALCANEUS STOP SCREW
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2013-12-13

    (77 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Normed® Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients. The screws are intended to block forward and medial displacement of the allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Adult - additive subtalar alignment for flat foot. Children - flexible flat foot treatment in children and adolescents
    Device Description
    The Normed Pellegrin Calcaneus Stop Screws are threaded, cannulated, tapered screws. They designed to be inserted into the calcaneus bone of the foot for subtalar arthoroereisis. They are made from CrNiMO Stainless Steel for Surgical Implants (ASTM F138. ISO 58321). The implant is offered in 3 lengths - 25mm, 30mm and 35mm. The implants are provided non-sterile and singleuse only. The instruments are non-sterile and reusable.
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    K Number
    K123347
    Device Name
    NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Date Cleared
    2013-08-02

    (275 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORMED MEDIZIN-TECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for: - · skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis - · primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss - · post-traumatic surgery.
    Device Description
    The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability.
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