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FDA 510(k), K151692, BioArchitects Patient Specific Cranial/Craniofacial Plate
FDA 510(k), K151692, BioArchitects Patient Specific Cranial/Craniofacial Plate
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510(K) Number: K151692
Device Name: BioArchitects Patient Specific Cranial/Craniofacial Plate
Manufacturer: BioArchitects USA, LLC
Device Classification Name: plate, cranioplasty, preformed, non-alterable
Regulation Number: 882.5330
Classification Product Code: GXN
Date Received: 06/23/2015
Decision Date: 11/20/2015
Regulation Medical Specialty: Neurology
Device Name: BioArchitects Patient Specific Cranial/Craniofacial Plate
Manufacturer: BioArchitects USA, LLC
Device Classification Name: plate, cranioplasty, preformed, non-alterable
Regulation Number: 882.5330
Classification Product Code: GXN
Date Received: 06/23/2015
Decision Date: 11/20/2015
Regulation Medical Specialty: Neurology
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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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