510(k) K163446
K163446 is an FDA 510(k) premarket notification submitted by Axogen Corporation for the device "AxoGen Nerve Cap". The FDA issued a decision of Substantially Equivalent on August 8, 2017. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Axogen Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2017
- Date Received
- December 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type