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.
Fibulink Syndesmosis Repair Kit (Akros Medical*), Anatomic Total Knee (Amplitude*), Facilis Pedicle Screw System (Baui Biotech*), GEO Bone Screw (Gramercy Extremity Orthopedics*), Roccia ACIF Intervertebral Fusion System (Silony Medical*), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens*)
View the full list of orthopaedic 510(k)s for January 2017 here.
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.
Fibulink Syndesmosis Repair Kit (Akros Medical*), Anatomic Total Knee (Amplitude*), Facilis Pedicle Screw System (Baui Biotech*), GEO Bone Screw (Gramercy Extremity Orthopedics*), Roccia ACIF Intervertebral Fusion System (Silony Medical*), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens*)
View the full list of orthopaedic 510(k)s for January 2017 here.
You are out of free articles for this month
Subscribe as a Guest for $0 and unlock a total of 5 articles per month.
You are out of five articles for this month
Subscribe as an Executive Member for access to unlimited articles, THE
ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.
Copy to clipboard 
