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510(k) Data Aggregation

    K Number
    K243889
    Device Name
    Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
    Manufacturer
    Date Cleared
    2025-04-02

    (105 days)

    Product Code
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orthocell Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Remplir is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    Remplir™ is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Remplir™ is a single-ply sheet of porcine-derived, non-crosslinked collagen. It presents as a soft and pliable, white to off-white membrane with distinct smooth and rough surfaces. The primary aim of surgical repair is to re-establish nerve continuity so that regenerating axons are guided into the distal nerve stump with minimal loss of nerve fibres at the repair site. Remplir™ is designed to protect the injured nerve. The device can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form. It is wrapped around the site of nerve repair, intended to provide a favourable environment for nerve regeneration and prevent ingrowth of connective tissue. Remplir™ is supplied as a single device in a double PETG/Tyvek blister pack in a labelled cardboard box. Remplir™ is available in 4 size variants for the convenience of clinicians (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm, 40 mm x 50 mm.). All size variants are identical in composition and function.
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    K Number
    K201241
    Device Name
    Striate+™
    Manufacturer
    Date Cleared
    2021-01-11

    (248 days)

    Product Code
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orthocell Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Striate+TM is indicated for use in: - augmentation around implants placed in immediate extraction sockets - augmentation around implants placed in delayed extraction sockets - filling of bone defects after root resection or removal of retained teeth - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in intrabony periodontal defects
    Device Description
    Striate+TM is an implantable biocompatible, sterile, resorbable collagen barrier membrane intended for use in dental guided bone and guided tissue regeneration procedures. Striate+1M has a bilayer structure (rough and smooth sides). The rough side, placed facing the bone defect, is composed of a loose distribution of collagen bundles allowing ingrowth of bone forming cells. The smooth side, facing the soft tissue, is composed of densely packed collagen bundles forming a barrier to soft tissue ingrowth into the defect. Striate+TM is supplied dry and can be easily trimmed to the required size. The collagen material becomes soft and pliable when hydrated allowing conformation to the repair site. Striate+TM has sufficient mechanical strength to be sutured in place, if required, and is gradually resorbed into the surrounding tissue. Striate+TM is sterilized with gamma radiation. Striate+TM is provided in the following sizes: 15 mm x 20 mm, 20 mm x 30 mm x 40 mm, 40 mm x 50 mm.
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