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510(k) Data Aggregation
K Number
K181035Device Name
AOS Small Fragment Plating System Lite
Manufacturer
Advanced Orthopaedic Solutions, Inc. (AOS)
Date Cleared
2018-08-24
(128 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Advanced Orthopaedic Solutions, Inc. (AOS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.
Device Description
The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
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K Number
K171606Device Name
AOS Anterolateral Proximal Humeral Plate
Manufacturer
Advanced Orthopaedic Solutions, Inc. (AOS)
Date Cleared
2017-06-22
(21 days)
Product Code
KTW
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Advanced Orthopaedic Solutions, Inc. (AOS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus
Device Description
The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.
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K Number
K163014Device Name
AOS Small Bone Nailing System
Manufacturer
Advanced Orthopaedic Solutions, Inc. (AOS)
Date Cleared
2017-01-24
(88 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Advanced Orthopaedic Solutions, Inc. (AOS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
Device Description
The AOS Small Bone Nail is a titanium alloy (Ti-6Al-4V) intramedullary nail available in various lengths (110mm to 260mm) and diameters (2.5mm to 5.0mm). The nail is compatible with use of 3.5mm and 2.7mm cortical locking screws that allow for additional fracture fixation and locking capabilities.
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