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FDA 510(k), K142648, SPINEDESIGN Spine Surgery Planning (Software Application)
FDA 510(k), K142648, SPINEDESIGN Spine Surgery Planning (Software Application)
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510(K) Number: K142648
Device Name: SPINEDESIGN Spine Surgery Planning (Software Application)
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 09/17/2014
Decision Date: 05/22/2015
Regulation Medical Specialty: Radiology
Device Name: SPINEDESIGN Spine Surgery Planning (Software Application)
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 09/17/2014
Decision Date: 05/22/2015
Regulation Medical Specialty: Radiology
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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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