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510(k) Data Aggregation
K Number
K142419Device Name
Mini and Micro Fragments Reconstruction System-NEOFIX
Manufacturer
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
Date Cleared
2014-12-16
(110 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Device Description
Mini and Micro Fragments Reconstruction System – NEOFIX consists of plates and screws in a variety of designs and sizes. Straight plates are provided in various lengths and may be contoured to adapt to patient specific anatomy. Straight plates are available with screw holes to accommodate non-locking and locking screw designs. Plates also are provided in various geometric configurations that are commonly used in trauma and reconstructive surgery. The plates range in thickness from 0.7 mm to 2.7 mm, and are manufactured from commercially pure titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications or Ti-6Al-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Self-tapping cortical screws are provided in locking and non-locking designs. The locking screws are provided with a thread diameter of 2.4 mm with a hexalobular instrument interface (Star Head) and a tapered thread tip to facilitate insertion. Locking smooth pins also are provided with a diameter of 2.4 mm in various lengths. The smooth pins are used with the Distal Radius Volar Plates. Non-locking cortical self-tapping screws are provided with thread diameters of 1.5, 2.0, 2.3, 2.4 and 2.7 mm, and in various lengths from 5 mm to 32 mm. The non-locking screws with thread diameters of 1.5, 2.0 and 2.3 mm have a cruciform instrument interface; the nonlocking screws with diameters of 2.4 and 2.7 mm have a hexalobular instrument interface. All screws are manufactured from Ti-6AI-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
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K Number
K132653Device Name
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
Manufacturer
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
Date Cleared
2014-05-14
(261 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.
Device Description
The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
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