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FDA 510(k), K051525, ARX SPINAL SYSTEM
FDA 510(k), K051525, ARX SPINAL SYSTEM
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510(K) Number: K051525
Device Name: ARX SPINAL SYSTEM
Manufacturer: AMEDICA CORP.
Device Classification Name: spinal vertebral body replacement device
Regulation Number: 888.3060
Classification Product Code: MQP
Date Received: 06/08/2005
Decision Date: 02/17/2006
Regulation Medical Specialty: Orthopedic
Device Name: ARX SPINAL SYSTEM
Manufacturer: AMEDICA CORP.
Device Classification Name: spinal vertebral body replacement device
Regulation Number: 888.3060
Classification Product Code: MQP
Date Received: 06/08/2005
Decision Date: 02/17/2006
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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