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FDA 510(k), K111863, SIGNATURE PLANNER,SIGNATURE GUIDES
FDA 510(k), K111863, SIGNATURE PLANNER,SIGNATURE GUIDES
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510(K) Number: K111863
Device Name: SIGNATURE PLANNER,SIGNATURE GUIDES
Manufacturer: MATERIALISE N.V.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Number: 888.3350
Classification Product Code: JDI
Date Received: 06/30/2011
Decision Date: 06/15/2012
Regulation Medical Specialty: Orthopedic
Device Name: SIGNATURE PLANNER,SIGNATURE GUIDES
Manufacturer: MATERIALISE N.V.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Number: 888.3350
Classification Product Code: JDI
Date Received: 06/30/2011
Decision Date: 06/15/2012
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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