Profile: Brasseler USA™ offers a line of surgical power accessories including both rotary cutters and surgical saw blades for orthopaedic, neuro, ENT, cardiovascular & oral-maxillofacial surgeons. We sell domestically under the Brasseler USA™ brand name and to international markets under the brand Tava Surgical™. We have ISO-13485 and CE mark certification to maintain and ensure our ongoing quality management processes. Our XK-PRO 100™ high speed drill system is a compact, lightweight design that renders new technological & performance standards for a combination of surgical procedures. Our PneuMicro™ is a small bone power system offers precision with ease of operation & can be utilized for all small bone procedures to include oral, maxillofacial, podiatric, and otology techniques.

The company was founded in 1987, has ~150 employees and is ISO, CE certified.

FDA Registration Number: 2025102

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• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Amputation Saws

• Battery

• Blades

• Bone Cutting Blade

• Bone Mill (FDA Code: LYS / 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.

• Burr

• Cast Cutting Saw Blade

• Cranial Burr

• Drills

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)

• Handpieces

• High Speed Drills

• Large Bone Battery Power System

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

• Manual Pupillometer (FDA Code: HLH / 886.1700) A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

• Micro Drill Module

• Micro Wire Driver

• Orthopedic Burr (FDA Code: HTT / 888.4540)

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

• Orthopedic Power Systems, Large Bone Battery Power System

• Orthopedics, High Speed Drills System

• Oscillating Saw

• Oscillating Saw Blades

• Pneumatic Drill Motor (FDA Code: HBB / 882.4370) A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

• Pneumatic Neurosurgical Drill Systems

• Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ / 878.4820)

• Podiatric Burr

• Powered Saw and Accessories (FDA Code: HAB / 878.4820)

• Reciprocating Saw Module

• Replacement Cutters

• Sagittal Saw

• Sagittal Saw Blades

• Saws (FDA Code: HSO / 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.

• Saws Instruments

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Simple Powered Trephines & Accessories (FDA Code: HBE / 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

• Small Bone Electric Power Systems

• Small Bone Pneumatic Power Systems

• Smooth Fixation Pin (FDA Code: HTY / 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.

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Sternal Saw

• Surgical Drills

• Surgical Drills & Reamers

• Surgical Equipment, Blades & Burrs

• Surgical Hand Pieces

• Surgical Large Bone Power System

• Surgical Saw Blade

• Threaded Fixation Pin (FDA Code: JDW / 888.3040)