Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name cuff, nerve
510(k) Number K163446
Device Name AxoGen Nerve Cap
Applicant
AxoGen Corporation
13631 Progress Blvd
Alachua,  FL  32615
Applicant Contact Mark L. Friedman
Correspondent
New South Regulatory, LLC
223 Coventry Road
Decatur,  GA  30030
Correspondent Contact Wendy Perreault
Regulation Number882.5275
Classification Product Code
JXI  
Date Received12/08/2016
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-