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510(k) Data Aggregation

    K Number
    K203855
    Device Name
    CoNextions TR Tendon Repair System
    Manufacturer
    CoNextions Medical
    Date Cleared
    2022-04-22

    (477 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications: - Digital Flexor Tendons - Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
    Device Description
    The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
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    K Number
    K193209
    Device Name
    Wego-Stainless Steel
    Manufacturer
    Foosin Medical Supplies Inc., Ltd.
    Date Cleared
    2020-02-19

    (90 days)

    Product Code
    GAQ, GAO
    Regulation Number
    878.4495
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
    Device Description
    The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
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    K Number
    K183472
    Device Name
    DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
    Manufacturer
    Synthes (USA) Products LLC
    Date Cleared
    2019-03-13

    (89 days)

    Product Code
    FTM, GAQ
    Regulation Number
    878.3300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma. The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair. The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
    Device Description
    The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium. The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle. The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.
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    K Number
    K181607
    Device Name
    Thorecon Rigid Fixation System
    Manufacturer
    A&E Medical Corporation
    Date Cleared
    2018-10-12

    (115 days)

    Product Code
    JDQ, GAQ, HRS, HWC
    Regulation Number
    888.3010
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thorecon Rigid Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.
    Device Description
    The Thorecon Rigid Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Sternal Cable of similar material. The Thorecon Rigid Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum, are manufactured from 420 or Custom 470 stainless steel. Thorecon devices are all single-use. The plates, complete with the necessary screws and instruments (torque driver and tensioner/cutter) required for completion of the surgery, are provided sterile in a disposable kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.
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    K Number
    K173579
    Device Name
    Thorecon™ Fixation System
    Manufacturer
    A&E Medical Corporation
    Date Cleared
    2018-02-12

    (84 days)

    Product Code
    JDQ, GAQ, HRS, HWC
    Regulation Number
    888.3010
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.
    Device Description
    The Thorecon Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Pioneer Sternal Cable of similar material. The Thorecon Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum are manufactured from 420 or Custom 470 stainless steel. Thorecon Fixation System devices are all single-use. The plates, complete with the necessary screws and instruments (screw driver and tensioner/cutter) required for completion of the surgery are provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.
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    K Number
    K172146
    Device Name
    MERISTEEL
    Manufacturer
    M/s. Meril Endo Surgery Private Limited
    Date Cleared
    2018-02-01

    (199 days)

    Product Code
    GAQ, GAO
    Regulation Number
    878.4495
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
    Device Description
    MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel. This suture is available undyed and uncoated. MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes. Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands
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    K Number
    K170767
    Device Name
    Surgical Stainless Steel Suture, Stainless Steel Suture
    Manufacturer
    Ethicon, Inc.
    Date Cleared
    2017-11-01

    (232 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
    Device Description
    Stainless Steel Suture is a sterile monofilament or multifilament, non-absorbable sterile surgical suture composed of 316L stainless steel. The suture is also available coated with polyethylene. Stainless Steel Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. Stainless Steel Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for Sterile Non-Absorbable Strands and the United States Pharmacopoeia (USP) for Non Absorbable Surgical Sutures. The European Pharmacopoeia recognizes units of measure Metric and Ph. Eur. sizes as equivalent which is reflected on the labeling. Stainless Steel Suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed. Implantation studies in animals show that no significant change in the retention of tensile strength of the suture occurs during the lifetime of the implantation.
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    K Number
    K161726
    Device Name
    E-Pack Procedure Kit
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2016-07-12

    (20 days)

    Product Code
    GAM, FTL, FZP, GAN, GAQ, GAW, LDF
    Regulation Number
    878.4493
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.
    Device Description
    Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II. The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.
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    K Number
    K143582
    Device Name
    MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
    Manufacturer
    RESORBA MEDICAL GMBH
    Date Cleared
    2015-10-29

    (315 days)

    Product Code
    GAW, GAP, GAQ, GAR, GAT, MXW
    Regulation Number
    878.5010
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
    Device Description
    The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
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    K Number
    K141007
    Device Name
    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2014-09-25

    (160 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.
    Device Description
    Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".
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