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510(k) Data Aggregation
(30 days)
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors
- Blood vessels to occlude blood flow for controlling bleeding/hemostasis in the peripheral vasculature
The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.
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(248 days)
The OsteoCentric Navigated Instruments are intended to be used during the preparation and placement of OsteoCentric Pedicle Fasteners during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The OsteoCentric Navigated Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The OsteoCentric Navigated Instruments System is a set of reusable surgical instruments for use with the Medtronic® StealthStation™ S8 Navigation System to assist surgeons in precisely locating anatomical structures in either open or percutaneous procedures for the placement of pedicle screws. The OsteoCentric Navigated Instruments are intended for use with the OsteoCentric Pedicle Fasteners Additionally, the submission includes a hybrid technique for placement of the Integrity SI® Fusion implants.
The OsteoCentric Navigation Instrument System includes navigated probes, taps, drills, and drivers and are manufactured from medical grade stainless steels per ASTM F899, ASTM F276, and ASTM F138.
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(85 days)
Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
S2AI Screws: The OLYMPIC Posterior Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to OLYMPIC posterior rods the OLYMPIC S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Spinal tumor
- Pseudarthrosis
- Failed previous fusion
Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
S2AI Screws: The MASADA Modular Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to MASADA posterior rods the MASADA S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.
The MASADA Modular Spinal Fixation System S2AI Screw System consist of an assortment of implants in various lengths and diameters, and associated instrument sets for both Open and minimally invasive (MIS) approaches. The S2AI bone screw implant component made from Titanium alloy (Ti-6Al-4V-ELI) as described by ASTM F136. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and provide foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, the MASADA S2AI Screw System can be placed into the S1 pedicle. It is designed for connection to the MASADA Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods.
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(88 days)
The SiNAPTIC Osteotomy Wedge System is intended to be used for internal bone fixation for fractures or osteotomies in the ankle and foot, such as:
- Opening wedge osteotomies of the bones of the foot, including osteotomies for Hallux Valgus
- Opening wedge of the medial cuneiform or Cotton osteotomies.
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z-Osteotomy)
- Metatarsal Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
- Hindfoot osteotomies such as Ankle fusion and Subtalar fusion
The Osteotomy Wedge System MTP Wedges are intended to be used for internal fixation of metatarsal bones that have been surgically prepared (osteotomy) for correction of deformity.
The Osteotomy Wedge System is indicated for use with supplemental fixation.
The Osteotomy Wedge System is not indicated for use in the spine.
The Osteotomy Wedge System devices are a sterile, single use Silicon Nitride (Si₃N₄) implants. The wedges are designed in a variety of shapes, each available in multiple footprints and thickness. The Osteotomy Wedge System is intended to be used for internal bone fixation for opening or lengthening osteotomies in the foot and ankle. The wedges contain an insertion feature as well as a central, open area for packing graft material or insertion of supplemental fixation.
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(270 days)
The On Call® Sure GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.
The On Call® Sure GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure Sync GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.
The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
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(79 days)
The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.
The ORA Method LED Gua Sha (Model: GS-04) is a hand-held, battery-powered device used for the treatment of full-face and decolletage wrinkles by emitting LED red(630nm) and infrared(830nm) light. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable,charging base, Goggles,storage bag and instruction manual.
The device have two functions:
A) Red and infrared irradiation function:The device emits energy in red and infrared region of the spectrum to reduce wrinkles on the face and decolletage;
B) Vibration and Gua Sha function. The device generates micro-vibration at a frequency of 200 Hz via its built-in micro motor. When used in conjunction with Gua Sha operation, it provides a soothing massage to the skin intended for relaxing the skin.
The recommended treatment time is 10 minutes per area. If you need to continue treatment, simply turn on the device again.
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(27 days)
The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
The Orca Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Orca Air/Water and Suction Valves are endoscopic channel accessories that attach to the Air/Water and Suction ports on the endoscope handle to control the amount of air/water flow and suction of an endoscope.
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(30 days)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.
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(230 days)
The OsteoProbe is a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.
OsteoProbe is a bone microindentation device. It is a prescription device per 21 CFR Part 801.109. The device includes a single-use disposable component and reusable components. The single-use disposable component has a Spaulding classification of critical and is provided sterile. The reusable components have a Spaulding classification of non-critical and must be reprocessed (cleaning and intermediate-level disinfection) between each use. The device has one accessory: a single-use, disposable sterile cover.
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(183 days)
The OptiLUV device is a handheld device intended to emit energy in the RF spectrum to provide topical heating for the purpose of elevating facial tissue temperature for a temporary relief of minor pain and the temporary increase in local blood circulation.
The OptiLUV device is a non-invasive, non-ablative device that delivers RF energy into the skin to generate heat through electrical impedance in the dermis. The device consists of the following components and accessories: the OptiLUV device, the USB Charging Cord, and the OptiLUV Preparation Balm.
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