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FDA 510(k), K140178, ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA 510(k), K140178, ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
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510(K) Number: K140178
Device Name: ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Manufacturer: ELLIPSE TECHNOLOGIES, INC.
Device Classification Name: growing rod system- magnetic actuation
Regulation Number: 888.3070
Classification Product Code: PGN
Date Received: 01/24/2014
Decision Date: 02/27/2014
Regulation Medical Specialty: Orthopedic
Device Name: ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Manufacturer: ELLIPSE TECHNOLOGIES, INC.
Device Classification Name: growing rod system- magnetic actuation
Regulation Number: 888.3070
Classification Product Code: PGN
Date Received: 01/24/2014
Decision Date: 02/27/2014
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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