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The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment. The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.

The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft. The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.

The Disc-FX System is intended for use in ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications. The Disc-FX® System consists of the following components: 1. Trigger Flex® Bipolar System 2. Triager Flex® Depth Stop 3. Surgical guidewires 4. Straight cannula 5. Beveled cannula 6. Tapered dilator 7. Trephine

The Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partially-insulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of <1hr (transient). It is composed of 17-4PH medical-grade stainless steel, ABS plastic, PFA, PVC, and copper. The biocompatibility of patient contacting materials has been assured through appropriate testing in accordance with ISO 10993-1. The Cobbra™ RF Tissue Dissector is individually-packaged and supplied EtO-sterilized for single use. It is available in five models which differ only by the diameter of the electrode: RF-COBB/XS (0.25 in.), RF-COBB/S (0.375 in.), RF-COBB/M (0.5 in.), RF-COBB/L (1.0 in.), and RF-COBB/XL (1.5 in.).

The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation. The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip. All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three fundamental configurations: (1) loop (round loop, diamond loop, and triangle loop), (2) ball, and (3) blade (fine wire, needle, and spatula).

The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-Max® RF Generators (510(k) K100390). For optimal performance the Surgi-Max® Plus generator (510(k) K100390) is recommended. The Meddusa™ Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration <24 hrs. The Meddusa Bipolar System is classified as Sterile, Surgically Invasive, Active Device, with intended patient contact for a period for <1hr (Transient). The Meddusa Bipolar System is intended to be used with the elliguence Surgi-Max Plus Radiofrequency generator (510(k) K100390). The Surgi-Max emits high frequency, lowtemperature radiowaves which is directed to the Meddusa Bipolar System tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The timevarying voltage produced by the electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

Orthopedic, arthroscopic, spinal, and neurosurgical For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist. Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps. Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis. The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered. This device is designed to comply with international safety standards including applicable IEC series electrical safety standards. The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode. Three output waveforms are provided: CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation. CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate. HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.