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 Arthroscope
510(k) Number K020457
Device Name AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
Applicant
Axiamed, Inc.
5200 Wilson Rd.
Suite 150
Edina,  MN  55424
Applicant Contact W ALLEN PUTNAM
Correspondent
Axiamed, Inc.
5200 Wilson Rd.
Suite 150
Edina,  MN  55424
Correspondent Contact W ALLEN PUTNAM
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/11/2002
Decision Date 09/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-