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FDA 510(k), K163446, AxoGen Nerve Cap
FDA 510(k), K163446, AxoGen Nerve Cap
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510(K) Number: K163446
Device Name: AxoGen Nerve Cap
Manufacturer: AxoGen Corporation
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 12/08/2016
Decision Date: 08/08/2017
Regulation Medical Specialty: Neurology
Device Name: AxoGen Nerve Cap
Manufacturer: AxoGen Corporation
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 12/08/2016
Decision Date: 08/08/2017
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
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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