Orthovita

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Web: http://www.orthovita.com
E-Mail:
Address: 77 Great Valley Parkway, Malvern, Pennsylvania 19355, USA
Phone: +1-(610)-640-1775 | Fax: +1-(610)-640-2603 | Map/Directions >>
 
 

Profile: Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fractures. Our autograft is the gold standard, which provides three essentials of effective healing including Scaffold, Cells(osteogenesis) and Signal(osteoinduction). Vitoss Scaffold delivers an ideal environment for cells and signals from the site or from added bone marrow. Our Vitagel Surgical Hemostat is a FDA approved Class III medical device used to control bleeding and facilitate healing while utilizing the patient's own biology. It benefits include autologous blood source, requires ~10 mL's of blood, can be prepared without needles, no capital equipment expense, and FDA approved as a surgical hemostat.

The company was founded in 1992. NASDAQ:VITA (SEC Filings)

FDA Registration Number: 2530131

28 Products/Services (Click for related suppliers)  
• Anterior Lumbar Spacer Systems
• Artificial Hydroxyapatite
• Artificial Hydroxyapatite Orbital Implant
• Bio-Eyes Hydroxyapatite Orbital Implant
• Bioabsorbable synthetic spacers
• Biopsy Instruments (FDA Code: KNW / 876.1075)
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Biopsy Instruments (FDA Code: KNW / 876.1075)
• Bone Regeneration
• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045)
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
• Catheter Needle (FDA Code: GCB / 878.4200)
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
• Cement Dispenser (FDA Code: KIH / 888.4200)
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.
• Collagen-Based Absorbable Hemostatic Agent (FDA Code: LMF / 878.4490)
An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.
• Enteral Irrigation Kit w/Piston Syringe
• Hydroxyapatite
• Hydroxyapatite Coated Implants
• Hydroxyapatite Orbital Implants
• 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.
• Percutaneous Biopsy Device (FDA Code: MJG / 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.
• Piston Syringe (FDA Code: FMF / 880.5860)
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
• Porous hydroxyapatite orbital implants
• Reamer (FDA Code: HTO / 888.4540)
• Removable synthetic spacers
• Soft Tissue Healing Technology
• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.
• Surgical Stylet (FDA Code: GAH / 878.4800)
• Synthetic Spacers
• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200)
• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027)
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

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