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: KXA
Date Received: 01/05/2015
Decision Date: 04/24/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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