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510(k) Data Aggregation
K Number
K081097Device Name
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
Manufacturer
ORTHOPEDIATRICS, LLC
Date Cleared
2008-06-03
(47 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIATRICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
Device Description
The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
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K Number
K073344Device Name
ORTHOPEDIATRICS PLATING SYSTEM
Manufacturer
ORTHOPEDIATRICS, LLC
Date Cleared
2008-02-19
(83 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIATRICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.
Device Description
The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments.
- Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards.
- Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process.
The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).
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