Friday, September 11, 2009

510(K) Approvals for August 2009

On Thursday, September 10th, the FDA announced 510(k) approvals for medical device products, here is the list:

Allez-Spine: Laguna Size 8 Pedicle Screw System
CardoMedical: Anterior Plating System, (I thought they had the rights to Vertebron?)
Custom Spine: Regent Anterior Cervical Plating System, A ruler or governor, how lame of a name?
EBI: IBEX Spinal System
Globus: Revere 6.35mm Stabilization System (Is this another quarter inch system?)
Globus: Truss Thoracolumbar Plating System
Medical Designs, LLC: Asfora Bullet Cage (No need to elaborate)
Medtronic: Vertex Recon System
Medtronic: Modification to the TSRH
Signus: Monopoly (Easy Money) Pedicle Screw System

As we analyze the ongoing trends in the industry, we continue to see companies glutting the market with more me too products. As the Spine Blogger has opined, the more "me too" products, the more hospitals justify capping pricing per procedure. The Spine Blogger wants to know what you think?


  1. US Spine update - another 2 choose to leave...

  2. Joseph: What are you hearing about the departures at U.S. Spine? We would like to know.

  3. Can't say too much at this time in order to protect source sounds like the company is relocating too.