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510(k) Data Aggregation
K Number
K021662Device Name
MAGLY 6.5MM CANNULATED SCREWS
Manufacturer
MAGLY ORTHOPEDICS, LLC
Date Cleared
2002-08-12
(84 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MAGLY ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Magly 6.5mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.
Indication(s) for Use:
- Femoral neck fractures
- Metaphyseal fractures of the distal femur and tibia
- Fractures of the tibial plateau
- Fractures of the humerus, olecranon process, scapuls, and os calcis
- Fractures of the sacrum, acetabulum, and pelvic ring
- Fixation of the ileo-sacral joint
- Fusions of the foot and ankle
Device Description
Magly 6.5mm Cannulated Screws are of a single thread profile with a nominal major diameter of 6.5mm and can be used in conjunction with a guide wire for precise placement.
At the distal tip the screws will incorporate 20mm of thread and will embody five cutting flutes that are used for reaming and tapping the thread profile. Located at the thread runout to the shank, we placed two reverse cutting flutes, located 180° to each other, to assist in the removal of the screw.
The screws will be available in 5mm incremental lengths, from 30mm-150mm.
Magly 6.5mm Cannulated Screws will be manufactured from titanium alloy
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K Number
K021579Device Name
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
Manufacturer
MAGLY ORTHOPEDICS, LLC
Date Cleared
2002-08-09
(87 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MAGLY ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails
Device Description
The screws are fully threaded from the distal tip to approximately 1mm to 2mm under the head. The distal end will embody a spherical shape at the tip and four cutting flutes used for tapping the thread profile.
The locking screws will be available in 2mm incremental lengths, measured from under the head to the distal tip, the 4.0mm from 16mm-80mm and the 5.5mm from 20mm-120mm.
Magly 4.0 and 5.5mm Locking Screws are manufactured from titanium alloy.
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K Number
K020562Device Name
APEX INTRAMEDULLARY NAIL SYSTEM
Manufacturer
MAGLY ORTHOPEDICS, LLC
Date Cleared
2002-05-16
(85 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
MAGLY ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Low subtrochanteric fractures
- Pseudarthrosis and corrective osteotomies
- Transverse fractures
- Pathologic fractures, impending pathologic fractures, and tumor resections.
- Oblique and spiral fractures
- Supracondylar fractures, including those with intra-articular extension
- Segmental fractures
- Ipsilateral femoral neck fractures
- Comminuted fractures
- Fractures proximal to total knee arthoplasty
- Fractures distal to a hip implant
- Nonunions and malunions.
- Acute bone lengthening and shortening
- Reamed and unreamed applications
- High Supracondylar fractures, including those with intra-articular extension.
Device Description
The APEX Intramedullary Nail System consists of intramedullary rods for fixation inside the canal of the tibia or femur. All the rods are cannulated and cylindrical in shape. The rods are available in a variety of diameters and lengths and have holes located the proximal and distal ends for fixation to bone by means of locking screws. An end cap is available. It screws into the threaded end of the nails to prevent bone ingrowth, which may hamper attachment of the extraction instrumentation. All components of the APEX Intramedullary Nail System are manufactured from titanium alloy (Ti-6Al-4V).
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