Amedica files FDA application for spinal implant spacers with porous silicon nitride center — 6 things to know

Written by Laura Dyrda | February 12, 2015 | Print  |

Amedica submitted a 510(k) application to the FDA for composite spinal interbody spacers with a porous silicon nitride center.

The company hopes to achieve clearance for the Valeo C Interbody with CsC Osteo-Conductive Scaffolding relating to its composite silicon nitride spinal interbody devices.

 

"The timer has now started with the FDA and we look forward to having the 510(k) reviewed and cleared," said Chairman and CEO Sonny Bal, MD. "We continue to keep our potential and existing customers in close contact and maintain preparedness to begin domestic shipments as soon as clearance is received."

 

Here are five things to know about the application:

 

1. Amedica is submitting the application after "impressive" outcomes from the CASCADE clinical trial.

 

2. The application has passed the FDA's administrative review.

 

3. The FDA now has 90 days to clear the Class II medical device for commercial distribution or seek additional information.

 

4. The FDA has confirmed it will review the product as a medical device.

 

5. Amedica will be able to commence manufacturing immediately after the FDA notifies clearance. The company also can market and sell the product at the United States at that time.

 

6. The product is cleared in Europe.

 

More articles on orthopedic devices:
52 spine, orthopedic devices receive FDA 510(k) clearance in January
Smith & Nephew launches new suture anchor
K2M CFO Gregory Cole sells 40k shares—5 things to know

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