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FDA 510(k), K101997, ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k), K101997, ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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510(K) Number: K101997
Device Name: ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Manufacturer: ELLIPSE TECHNOLOGIES, INC.
Device Classification Name: rod, fixation, intramedullary and accessories
Regulation Number: 888.3020
Classification Product Code: HSB
Date Received: 07/15/2010
Decision Date: 07/12/2011
Regulation Medical Specialty: Orthopedic
Device Name: ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Manufacturer: ELLIPSE TECHNOLOGIES, INC.
Device Classification Name: rod, fixation, intramedullary and accessories
Regulation Number: 888.3020
Classification Product Code: HSB
Date Received: 07/15/2010
Decision Date: 07/12/2011
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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