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FDA 510(k), K132290, SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
FDA 510(k), K132290, SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
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510(K) Number: K132290
Device Name: SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
Manufacturer: MATERIALISE N.V.
Device Classification Name: orthopaedic surgical planning and instrument guides
Regulation Number: 888.3030
Classification Product Code: PBF
Date Received: 07/23/2013
Decision Date: 04/10/2014
Regulation Medical Specialty: Orthopedic
Device Name: SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
Manufacturer: MATERIALISE N.V.
Device Classification Name: orthopaedic surgical planning and instrument guides
Regulation Number: 888.3030
Classification Product Code: PBF
Date Received: 07/23/2013
Decision Date: 04/10/2014
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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