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The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources. This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,

Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.

The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.

The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.

The plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6AI - 4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, KLS and W.L. Lorenz.

The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal I.D. of 1.25 mm (.050%) when combined with nonabsorbable sutures in a surgical application. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Shunt Connector

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.

The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including: cranial fixation, midface fixation, mandibular fixation, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation, zygomatic fixation. The device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.

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The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years.