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510(k) Data Aggregation
K Number
K213614Device Name
Cannulated Screws
Manufacturer
Date Cleared
2022-08-03
(261 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Maxxion Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.
The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.
Device Description
Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.
The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.
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K Number
K181843Device Name
MLP Special Locking Bone Plate System
Manufacturer
Date Cleared
2019-03-04
(236 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Maxxion Medical, LLC / Baumer SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
Device Description
The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures. The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.
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