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510(k) Data Aggregation
K Number
K163425Device Name
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
Manufacturer
NARANG MEDICAL USA CORPORATION
Date Cleared
2017-03-24
(108 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NARANG MEDICAL USA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NMUC Brand Small and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NMUC Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric or intertrochanteric zones. The system is indicated for use in adult patients only. All implants are for single use only
Device Description
NMUC brand small fragment and large fragment Osteosynthesis plating system consists of plates and screws in a variety of designs and made from Ti-6AI-4V (Titanium) alloy or stainless steel. Plates are provided in a straight design also in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screw designs. Screws are provided in, 3.5mm cortex self-tapping, 4.5 mm diameter cortex self-tapping and 2.7mm diameter self-tapping cortex locking, 3.5mm self-tapping cortex locking, 5.0mm cortex locking thread designs in various lengths.
DHS/DCS, systems are made from Ti-6AI-4V (Titanium) alloy or stainless steel and consists of DHS/DCS plates, lag screws, compression screws and 4.5mm diameter cortex screw selftapping. The plates are available with barrel length 25mm and 38 mm with angles variances between 130° to 150°. The DCS plate have angles of 95°.
The products are provided NON-STERILE only. Subsequent of being sold as NON-STERILE product, the intention is to achieve sterility by utilizing autoclaving method on parameters of SAL10-6 AAMI ST79 & ISO 17665-1.
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