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Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Compatible Implant Systems

All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.

Multi-Unit DAS System abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration

Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.

This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.

The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.

No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.

A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.

Table 1 Summary of Compatibilities

All zirconia superstructures for use with the subject device Multi-Unit DAS system will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the subject Multi-Unit DAS Dynamic Ti-base are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 15°

The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 0°

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2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The RÜSCH SoftSimplastic balloon catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity in ml and shaft size in French gauge (Fr.), Charrière (Ch.) or millimeters (mm) are indicated on the funnel of each individual catheter. They have a radiopaque contrast stripe along the shaft and are supplied sterile.

The following tip types are available: Couvelaire and Coudé/Mercier. Sizes range from 14 to 24 Ch./Fr. The catheters have a length of approximately 42 cm.

The RÜSCH SoftSimplastic balloon catheters are made of PVC uncoated. These catheters are only for short term usage. Maximum duration of use: Up to 30 days.

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The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to classify and enumerate WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph#, Lymph%, Neut#, Neut%, Other WBC#, and Other WBC% in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.

The Tru Hematology Test (part of the TruWellness Panel™) is intended for use in adults 18 years of age or older. It is not intended for use in diagnosing or monitoring critical disease states such as oncology.

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the Tru Analyzer and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

The Tru Analyzer is a benchtop instrument that fully automates sample processing, assay execution, and result reporting. Its touchscreen interface allows operators to control workflows, initiate tests, and review results with minimal training. The Single-Use Consumable Kit and blood sample are loaded into the analyzer drawer, where all necessary processing takes place. Internally, the Tru Analyzer integrates:

• A high-precision pipettor for automated sample and reagent handling.
• An onboard centrifuge to separate whole blood into plasma.
• A closed-loop thermal control system to maintain precise assay temperatures.
• A motion control system to fully automate sample processing.
• Dedicated detection modules for clinical chemistry, immunoassay, and hematology testing.
• A high-definition camera used to collect assay readings, image capture, and instrument quality control checks.
• An electronics board to manage individual module boards and associated firmware.
• An integrated computer running the instrument software, accessible via the touchscreen user interface.

The Tru Analyzer is factory-calibrated and continuously monitors its performance using optical sensing and electronic feedback mechanisms. Every time the analyzer is powered on or a Single-Use Consumable Kit (TruWellness Panel™) is loaded, the system runs an automated self-test to verify that it remains within calibration and is functioning properly. Internal quality control (QC) checks occur throughout the testing process to ensure the integrity of the analyzer, Disc, and Support Pack. If any self-test or QC check fails to meet system specifications, the Tru Analyzer will display an error code and next steps on the touchscreen interface.

The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the Tru Analyzer, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards of at the end of the run.

The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test is an in-vitro diagnostic device intended to classify and enumerate WBC, Lymph # and %, Neut # and %, Other WBC # and %, RBC, HGB, HCT, MCH, MCHC, MCV, and PLT in lithium-heparinized venous whole blood samples.

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The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Toro 88 Superbore Catheter is a variable stiffness, single lumen catheter designed to introduce interventional devices into the vasculature. The catheter shaft design includes stainless steel and nitinol wires and polymers of varying durometers. The catheter incorporates an internal lubricious liner to facilitate its advancement over a steerable guidewire or microcatheter. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a hub with Luer lock. The catheter is supplied sterile, for single use only.

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The SnugLit(TM) Wearable Phototherapy System is intended for use in the treatment of infant hyperbilirubinemia, commonly known as neonatal jaundice. The device can be used in a hospital or at home, by a licensed medical practitioner or by a caregiver under the supervision of a licensed medical practitioner.

The device has been designed for use with infants of weights between 1.5 – 5.5 kg (approximately 3.5 -12 lbs) and lengths between 40.5 - 57.5 cm (approximately 16 - 23 inches).

The SnugLit system is a phototherapy device that provides therapeutic blue light to infants using a Light Mat enclosed within a Disposable Swaddle. This system enables infants to receive phototherapy in a bassinet or while being held. The SnugLit is designed to deliver wrap-around phototherapy to infants while being swaddled.

The SnugLit is composed of a Light Mat, Controller, Disposable Swaddle, and Power Adapter.

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The TriMed Volar Plates are intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies that lend themselves to the principle of plate and screw fixation.

The following fracture configurations may be applicable for treatment using TriMed Volar Plates:

1. Fractures, non-unions or osteotomies of the radius

TriMed Volar Bearing Plates are intended to be used as an aid to the treatment of certain types for fractures, non-unions and osteotomies of the radius. Like every type of orthopaedic implant, these implants cannot be assumed to be uniformly effective without risk. Use of these implants is not a substitute for normal tissue healing. The TriMed Volar Plates are designed to provide additional constraint of movement of a fractured/osteotomized bone and are intended only as an aid to fix the injury in place during the healing process. These plates are made from 316L Stainless Steel per ASTM F138/F139. The new plates will be offered as part of TriMed Wrist Fixation system 3 (received FDA clearance under K222637). They will be made available in 3 sizes (13, 14 &16 holes) for left and right each.

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The Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.

The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older:

• Glucose (GLU): Carbohydrate metabolism disorders, including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Total Protein (TP): Variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
• Albumin (ALB): Numerous diseases involving primarily the liver and kidneys.

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the TruVerus™ and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the TruVerus™, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards at the end of the run.

The Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is intended for in vitro quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood samples.

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The Tornier Perform™ Reversed MonoPost Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of glenohumeral joint if native glenoid bone remains

All components are single use.

The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation

The Tornier Perform™ Reversed MonoPost Glenoid (Perform Mono) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

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The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.

This traditional 510(k) submission adds configurations of the previously cleared Tyber Medical Trauma Screws under K192975 and K153575. The Tyber Medical Trauma Screw is designed to allow compression and fixation between two adjacent bone segments. The screw is available with thread diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, and 9.0mm. The screw is configured to have either full thread, long thread, or short thread. The multiple thread lengths come in various options which can assist to ensure fit for various bone sizes. General trauma screws are intended for compression and fixation of bone.

This Submission also references Washers and Trays. The Trays are specific to the Tyber Medical Trauma Screws.

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