FDA clears SeaSpine's Shoreline ACS System: 5 points

Spinal Tech

SeaSpine earned FDA clearance for its Shoreline Anterior Cervical Standalone System.

Here are five points:

 

1. The Shoreline ACS System includes TruProfile technology, which provides a low-profile plate intended to "minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces."

 

2. The anterior plate is 1.6 mm thick.

 

3. The Shoreline ACS System features NanoMetalene surface technology, which offers a titanium surface and PEEK features, like biocompatibility, elasticity and radiographic visibility.

 

4. Specifically, NanoMetalene has a sub-micron layer of titanium molecularly bonded to Invibio's PEEK-OPTIMA polymer.

 

5. SeaSpine plans to executive a limited launch of the system over the next few months and anticipates a full commercial launch in the first half of 2017.

 

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