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.
Strategic orthopaedic-related 510(k)s issued in December 2015 include: Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21*), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical*), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies*), Internal Joint Stabilizer – Elbow (Skeletal Dynamics)
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...
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.
Strategic orthopaedic-related 510(k)s issued in December 2015 include: Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21*), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical*), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies*), Internal Joint Stabilizer – Elbow (Skeletal Dynamics)
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