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RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm. RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end. The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device. The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.

The BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.

The BONE MARROW MSC ASPIRATION KIT is a single use disposable needle intended for the aspiration / explant of bone marrow. The structure of BONE MARROW MSC ASPIRATION KIT device includes a cannula with a stylet inside, with a threaded insert and a rotating spacer that allow the precise retraction of the cannula to a determined length. Once the cannula has been inserted and positioned, the stylet can be removed and a syringe is connected to execute the aspiration. By manually rotating the rotating spacer, the cannula retracts, raising inside the bone marrow, in order to be able to perform aspiration / explant from fresh sites at different heights.

The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thorace and cervical regions of the spine.

The DISKOM is a single use, active, EO sterilized device, that shall be used by specialized personnel during discectomy procedures. The DISKOM is a disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus. DISKOM is composed by an INTRODUCER NEEDLE and a DISCECTOMY PROBE. The INTRODUCER NEEDLE is made of an aspiration cannula and an introducer stylet. The introducer needle is positioned on the disc (using CT / Fluoroscopic guide), then the stylet is removed and the cannula is used to position the discectomy probe. The DISCECTOMY PROBE contains a battery source DC motor that causes the internal mechanism to act as a screw conveyor to remove and retrieve the excised debris of the spine through the outer cannula and into the transparent collection container. The DISKOM is provided in two different models with two different cannula lengths (16cm and 8cm) and two different gauges cannulas (17G and 19G).

The medical devices object of this 510K are all needles for biopsy. The products could be classified in 3 families that are: - the needles for bone-marrow biopsy (In this family of needles for bone-marrow biopsy there is also a little group of devices intended for bone-marrow explants). In particular the indications for use for each different model are the followings: OSTEOBELL 'T': Needle for bone-marrow biopsy ORION: Needle for bone-marrow biopsy ILIAC-MARROW: Needle for bone-marrow biopsy OBSTERN: Needle for bone-marrow biopsy STERNOBELL: Needle for bone-marrow biopsy TOTALLY REMOVE: Needle for bone-marrow biopsy UNLUX SYSTEM: Needle for bone-marrow biopsy OSTEOBELL EXPLANT: Needle for bone-marrow explant ORION EXPLANT: Needle for bone-marrow explant ILIAC-MARROW EXPLANT: Needle for bone-marrow explant OBSTERN EXPLANT: Needle for bone-marrow explant STERNOBELL EXPLANT: Needle for bone-marrow explants - the semiautomatic quillotine needles for soft-tissue biopsy (breast, kidney, liver, prostate): SPEEDYBELL: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate) SPEEDYBELL DOPPIA CORSA: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate) SPEEDYBELL & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate) SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate) - the automatic guillotine needles for soft-tissues biopsy (liver): ESTER: automatic quillotine needle for soft-tissue biopsy (liver) ESTER & INTRODUTTORE: automatic guillotine needle for soft-tissue biopsy (liver)

The medical devices object of this 510K are all needles for biopsy, used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination (biopsy). The devices could be classified in 3 families that are: - the needles for bone-marrow biopsy, - the semiautomatic guillotine needles for soft-tissue biopsy and - the automatic quillotine needles for soft-tissue biopsy. All the needles are single use and sterile (ETO sterilization). All the needles are composed with an external cannula (tube) and an internal stylet (mandrel) both in AISI 304 stainless steel. The grip of the needles is in plastic (different depending from the model).