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FDA 510(k), K120368, CAPSTONE CONTROL SPINAL SYSTEM
FDA 510(k), K120368, CAPSTONE CONTROL SPINAL SYSTEM
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510(K) Number: K120368
Device Name: CAPSTONE CONTROL SPINAL SYSTEM
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 02/06/2012
Decision Date: 04/09/2012
Regulation Medical Specialty: Orthopedic
Device Name: CAPSTONE CONTROL SPINAL SYSTEM
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 02/06/2012
Decision Date: 04/09/2012
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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