510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163446Substantially Equivalent

AxoGen Nerve Cap

Axogen Corporation, Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163446 is the FDA 510(k) clearance record for AxoGen Nerve Cap, a class II device, cleared for Axogen Corporation on under FDA product code JXI (Cuff, Nerve). FDA records list 3 510(k) clearances for Axogen Corporation, from to . As of , FDA records show no recalls naming K163446.

Clearance record

Decision date
Received
(243 days to decision)
Product code
JXI Cuff, Nerve
Regulation
21 CFR 882.5275
Device class
Class II
Review panel
Neurology
Applicant
Axogen Corporation 13631 Progress Blvd., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXI

Trailing 12 months
2 clearances under product code JXI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260