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FDA 510(k), K150017, SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
FDA 510(k), K150017, SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
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510(K) Number: K150017
Device Name: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
Manufacturer: Manthan J Damani
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: 01/05/2015
Date Received: 04/24/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
Manufacturer: Manthan J Damani
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: 01/05/2015
Date Received: 04/24/2015
Decision Date: Substantially Equivalent (SESE)
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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