4 results
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65ms
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Sources: EU EUDAMED, US FDA
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Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
FDA Enforcement
Class II
·Terminated·Orthohelix Surgical Designs Inc·April 3, 2013
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
FDA Enforcement
Class II
·Terminated·Orthohelix Surgical Designs Inc·October 15, 2014
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
FDA Enforcement
Class II
·Terminated·Orthohelix Surgical Designs Inc·October 17, 2012
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
FDA Enforcement
Class II
·Terminated·Orthohelix Surgical Designs Inc·October 17, 2012