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510(k) Data Aggregation
K Number
K163279Device Name
Medtronic Transportation/Sterilization Cassettes
Manufacturer
Medtronic Sofamor Danek, USA, Inc.
Date Cleared
2017-02-23
(94 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Medtronic Sofamor Danek, USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic Transportation Cassettes are intended for use in healthcare facilities to organize, enclose, sterlize, transport, and store medical devices and other instrumentation between surgical uses. The Medtronic Transportation/Sterilization Cassettes are not intent own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Device Description
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices, which meet national or international standards. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation / Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components if the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA-cleared wrap must be used for sterilization and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the Medtronic Transportation/Sterilization Cassettes are effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
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K Number
K160528Device Name
ANATOMIC PEEK PTC Cervical Fusion System
Manufacturer
MEDTRONIC SOFAMOR DANEK, USA, INC.
Date Cleared
2016-03-28
(32 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC SOFAMOR DANEK, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The ANATOMIC PEEK™ PTC Cervical Fusion System is designed for use as a cervical interbody fusion device. These devices are manufactured from polyetheretherketone (PEEK OPTIMA™) each containing a commercially pure titanium coating along with tantalum markers. This device is to be used with autogenous and/or allogenic bone graft material (cancellous and/or corticocancellous bone chips). The ANATOMIC™ PEEK PTC Cervical Fusion System consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous or allogenic bone graft (cancellous and/or corticocancellous bone chips) material.
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