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.
Envision 3D: Image Guidance System (7D Surgical*); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare*); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical*)
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.
Envision 3D: Image Guidance System (7D Surgical*); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare*); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical*)
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