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FDA 510(k), K170818, Craniomaxillofacial Distraction System (CMFD)
FDA 510(k), K170818, Craniomaxillofacial Distraction System (CMFD)
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510(K) Number: K170818
Device Name: Craniomaxillofacial Distraction System (CMFD)
Manufacturer: Synthes USA Products, LLC
Device Classification Name: cranial distraction system
Regulation Number: 882.5330
Classification Product Code: PBJ
Date Received: 03/20/2017
Decision Date: 12/07/2017
Regulation Medical Specialty: Neurology
Device Name: Craniomaxillofacial Distraction System (CMFD)
Manufacturer: Synthes USA Products, LLC
Device Classification Name: cranial distraction system
Regulation Number: 882.5330
Classification Product Code: PBJ
Date Received: 03/20/2017
Decision Date: 12/07/2017
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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