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FDA 510(k), K140750, SHILLA GROWTH GUIDANCE SYSTEM
FDA 510(k), K140750, SHILLA GROWTH GUIDANCE SYSTEM
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510(K) Number: K140750
Device Name: SHILLA GROWTH GUIDANCE SYSTEM
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: growing rod system
Regulation Number: 888.3070
Classification Product Code: PGM
Date Received: 03/25/2014
Decision Date: 07/17/2014
Regulation Medical Specialty: Orthopedic
Device Name: SHILLA GROWTH GUIDANCE SYSTEM
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: growing rod system
Regulation Number: 888.3070
Classification Product Code: PGM
Date Received: 03/25/2014
Decision Date: 07/17/2014
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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