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FDA 510(k), K193423, VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
FDA 510(k), K193423, VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
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510(K) Number: K193423
Device Name: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Manufacturer: Icotec AG
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 12/09/2019
Decision Date: 05/22/2020
Regulation Medical Specialty: Orthopedic
Device Name: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Manufacturer: Icotec AG
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 12/09/2019
Decision Date: 05/22/2020
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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