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FDA 510(k), K070351, SPACE 360 DELIVERY SYSTEM
FDA 510(k), K070351, SPACE 360 DELIVERY SYSTEM
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510(K) Number: K070351
Device Name: SPACE 360 DELIVERY SYSTEM
Manufacturer: DFINE, INC.
Device Classification Name: cement, bone, vertebroplasty
Regulation Number: 888.3027
Classification Product Code: NDN
Date Received: 02/06/2007
Decision Date: 06/29/2007
Regulation Medical Specialty: Orthopedic
Device Name: SPACE 360 DELIVERY SYSTEM
Manufacturer: DFINE, INC.
Device Classification Name: cement, bone, vertebroplasty
Regulation Number: 888.3027
Classification Product Code: NDN
Date Received: 02/06/2007
Decision Date: 06/29/2007
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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