Bioretec Ltd.

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Contact: Mari Ruotsalainen
Web: http://www.bioretec.com
E-Mail:
Address: Hermiankatu 22, Modulight Building, Tampere FI-33720, Finland
Phone: +358-(20)-7789500 | Fax: +358-(3)-3170225 | Map/Directions >>

Profile: Bioretec Ltd. develops bioabsorbable device solutions for the fields of surgery. Our Activa™ products are novel bioabsorbable fixation devices for treatment of bone and cartilage fractures and have the desired strength and stiffness for safe bone tissue healing and good biocompatibility for uneventful bioabsorption of implant after surgery. Our products Activasin™ and Activascrew™ degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The ActivaScrew™ is constructed of bioabsorbable lactic/glycolic acid copolymer (PLGA). These polymers have safe medical use and degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The manufacturing process generates the high initial mechanical strength and stiffness of the screws. It is used in the presence of adequate immobilization, the ActivaScrew™ maintains accurate alignment of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot after surgical procedure.

The company is ISO13485:2003 certified.

FDA Registration Number: 3005536892
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997 Fax: +1-(512)-327-9998 E-Mail:

7 Products/Services (Click for related suppliers)

• Bone Fixation Screw (FDA Code: HWC / 888.3040)

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Depth Gauge (FDA Code: HTJ / 888.4300)

A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Small Depth Gauge (FDA Code: HTJ / 888.4300)

• Smooth Fixation Pin (FDA Code: HTY / 888.3040)