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When used as an interbody fusion device, the ProLift® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

The ProLift® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 26mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Expandable Spacer System components with components from any other system or manufacturer. The ProLift® Expandable Spacer System components should never be reused under any circumstances.

The ProLift® Lateral Fixated is an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral Fixated with components from any other system or manufacturer. The ProLift® Lateral Fixated components should never be reused under any circumstances.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis,
• Avascular necrosis of the humeral head,
• Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains,
• Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains.

The subject devices consist of a line extension of the SMR Shoulder System and the PRIMA Shoulder System. The new devices introduced with this 510(k) are SMR and PRIMA Glenospheres with diam. 40 and 44mm made of Vitamin E crosslinked UHMWPE (LimaVit) and corresponding CoCrMo humeral liners.

The PRIMA Humeral System consists of the following single use components:

• Anatomic configuration:
  • Stem
  • adaptor for humeral heads.
• Reverse configuration:
  • stem
  • reverse tray and polyethylene reverse insert, or
  • metallic reverse insert.

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The LZI Buprenorphine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine at the cutoff value of 5 ng/mL when calibrated against norburprenorphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Buprenorphine II Enzyme Immunoassay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, norbuprenorphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody would bind to free drug; the unbound norbuprenorphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Buprenorphine II Enzyme Immunoassay is a kit comprised of two reagents, R₁ and R₂, which are bottled separately but sold together within the kit.

The R₁ solution contains mouse monoclonal anti-norbuprenorphine antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R₂ solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with norbuprenorphine in buffer with sodium azide (0.09%) as a preservative.

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Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings. The intended patient population is Adults, Pediatrics, Infants and Neonates.

Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in flexible polyolefin bags, designed for safe and easy handling. The flexible polyolefin bags are prefilled with sterile water and feature a single polypropylene twist-off port used to transfer the sterile water to humidifier chambers using tubular feed sets. The humidifier chamber is then filled with sterile water from the bags via gravity. The device has a hanger to suspend the product during use.

Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.

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The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental laboratories or by dental professionals.

"Gradual Dental Zirconia Blank- GT(F) P1, GT(F) P2, and SP Series" are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO₂+ Y₂ O₃ + HfO₂+ Fe₂O₃+ Er₂O₃. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.

"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO₂ so that its final properties can be achieved.

"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are different from the predicate device as they have different manufacture process. GT(F) P1 and GT(F) P2 series use six-layer padding process to produce multi-layer aesthetic effect, while the SP series does not use padding process, produce single aesthetic effect.

GT(F) P1 and SP series have Flexural Strength of >800 MPA, They belong to Type II, Class 5 ceramics per ISO 6872.

GT(F) P2 series have Flexural Strength of >500 MPa, They belong to Type II, Class 4(a) ceramics per ISO 6872.

"Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series" are supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors.

The different colors are originated from the different constituent of color additives (such as Fe₂O₃, Er₂O₃); the different translucencies are originated from small difference in the amount of Y₂ O₃, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.

The GT(F) P1 and GT(F) P2 series are supplied in gradual changing translucencies, and multi-layer aesthetic effect. The SP series are supplied with no gradual changing translucencies, and in single-layer aesthetic effect.

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Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements.

Validated sterilization cycles of LifeUltra include:

Class B cycles

• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments, hand pieces, textiles, and porous loads (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate or wrapped/unwrapped loads (max 7 kg).

Class S cycles

• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments and hand pieces (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate loads (max 7 kg).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The autoclave is equipped with a vacuum system, which supports:

• Removal of residual air from packs and porous load and most kinds of tubes (rubber, Plastic etc.) by vacuum at the first stage of the cycle.
• Steam penetration into the load; resulting in effective sterilization.
• Temperature uniformity.
• Post sterilization drying phase

The device has a built-in thermal printer with the following feature:

• The Thermal printer can print the cycle data immediately after cycle completion.
• The print data includes Realtime values of Temperature (°C/°F) and pressure (Bar/kPa) including the overall cycle time.
• The print data also includes overall conditioning time, pressurizing time, sterilization time, and the drying time with the maximum and minimum temperature attained during the sterilization along with the Pass/Fail results.

LifeUltra™ is controlled by a micro-controller with installed software that has pre-set programs to run standard B, S sterilization cycles and test cycles. Saturated steam for sterilization is generated from distilled water, produced in an onboard water distiller, so users can directly tap into municipal facility water. For this feature, the device is programmed to run an automatic water distilling cycle and a manual tank descaling cycle. The integrated software manages the air-water-steam system through precision sensors, probes, and switches that both monitor and control the device's vital parameters in real-time, assuring safe and successful results. The operation of the device is through a back-lit display and control interface.

The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.

The chamber door has the following features protecting personnel from hazards:

• One door micro-switch indicates that the door is closed. Without this indication steam is not introduced into the chamber. An electrical door locking pin that blocks door opening during cycle operation. The micro-switch prevents opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
• Additionally, a mechanical lock that blocks door opening at positive pressure.

In addition, the following safety devices are installed in the autoclave to optimize its safe operation:

• A safety thermostat to prevent over-heating of the chamber heating elements.
• A safety thermostat to prevent over-heating of the steam generator.
• A pressure safety valve to prevent over-pressurizing of the chamber.

There is a municipal water inflow input port for up to 500 ppm. There are 2 output ports for demineralized water tank and wastewater tank overflow/drain outlet. The chamber is made of corrosion-resistant 316L stainless steel, and the door is made up of Aluminum Hard Anodized with Teflon coating. The outer covers are made of Carbon Steel with coating.

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Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Regrowth Cap (HRC) is a wearable device designed to treat androgenetic alopecia in both men and women. The cap utilizes LED light phototherapy to stimulate hair regrowth through a daily treatment session of approximately 10 minutes.

The system consists of a soft, comfortable textile cap embedded with LEDs, powered by a rechargeable battery. It includes driver electronics and is easily operated via a built-in switch button located on the cap. Hair Regrowth Cap device cannot operate while charging. The device has no communication function.

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The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.

The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.

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LacertaMatrix is indicated for use in the management of the following wounds:

• partial and full-thickness wounds
• pressure ulcers
• venous ulcers
• diabetic ulcers
• chronic vascular ulcers
• tunneled / undermined wounds
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• draining wounds

LacertaMatrix is a single use, non-pyrogenic wound dressing intended for use in local management of full thickness and partial thickness wounds. LacertaMatrix includes alligator derived hyaluronic acid (HA). LacertaMatrix is provided sterile in various size offerings up to 100cm² in a dual pouch configuration for aseptic transfer. Following placement, LacertaMatrix is gradually broken down and resorbed over time (typically over a period of within 2 weeks), as new tissue forms in its place.

This device is limited to only one-time application to the wound. This device can only be used once within 24 hours and should be completely remove by rinsing with PBS to remove any residual device. Second application is restricted. Please use other FDA cleared dressing.

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