Each month, ORTHOWORLD examines updates to FDA’s orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company’s first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.
In the following list, companies receiving a first orthopaedic-related 510(k) are denoted with an asterisk.
NanoFuse (Amend Surgical*), Arrowhead Mini-Rail Fixator (Arrowhead), Expandable Interbody System (Atlas Spine), DCM Kyphoplasty System (Dragon Crown Medical*), Kepler I Cervical Plate (Orbbo Surgical), RASL Repair Kit/Bone Screw (Radicle Orthopaedics*), Trauma System/Plates and Screws (Surgtech), BluePrint Patient Specific Instrumentation (Tornier/Wright Medical), Intra Medullary Endo-Transilluminating Device/Arthroscope (Wemed Bio-Tech*), Prophecy INVISION Pre-operative Navigation Alignment System (Wright Medical), Magnetos Bone Void Filler (Xpand Biotechnology*)
Each month, ORTHOWORLD examines updates to FDA's orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company's first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.
In the following list,...
Each month, ORTHOWORLD examines updates to FDA’s orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company’s first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.
In the following list, companies receiving a first orthopaedic-related 510(k) are denoted with an asterisk.
NanoFuse (Amend Surgical*), Arrowhead Mini-Rail Fixator (Arrowhead), Expandable Interbody System (Atlas Spine), DCM Kyphoplasty System (Dragon Crown Medical*), Kepler I Cervical Plate (Orbbo Surgical), RASL Repair Kit/Bone Screw (Radicle Orthopaedics*), Trauma System/Plates and Screws (Surgtech), BluePrint Patient Specific Instrumentation (Tornier/Wright Medical), Intra Medullary Endo-Transilluminating Device/Arthroscope (Wemed Bio-Tech*), Prophecy INVISION Pre-operative Navigation Alignment System (Wright Medical), Magnetos Bone Void Filler (Xpand Biotechnology*)
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