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.
Vantage Total Ankle (Exactech), Align Anterior Ankle Fusion Plate (Extremity Medical), Jazz Lock (Implanet), PROLIFT Expandable Interbody System (Life Spine), OrthAlign Plus UniAlign (OrthAlign), Tesera SC Standalone Anterior Cervical Plate (Renovis Surgical), S-Wire (Spinal Resources*), Interbody System (Surgtech*), Xspan Laminoplasty Fixation System (X-spine/Xtant Medical)
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.
Vantage Total Ankle (Exactech), Align Anterior Ankle Fusion Plate (Extremity Medical), Jazz Lock (Implanet), PROLIFT Expandable Interbody System (Life Spine), OrthAlign Plus UniAlign (OrthAlign), Tesera SC Standalone Anterior Cervical Plate (Renovis Surgical), S-Wire (Spinal Resources*), Interbody System (Surgtech*), Xspan Laminoplasty Fixation System (X-spine/Xtant Medical)
You’ve reached your limit.
We’re glad you’re finding value in our content — and we’d love for you to keep going.
Subscribe now for unlimited access to orthopedic business intelligence.
JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.





