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 Tester, Stiffness, Cartilage, Arthroscopic
510(k) Number K013429
Device Name ACTAEON PROBE
Applicant
Osteobiologics, Inc.
University Business Park
12500 Network, Suite 112
San Antonio,  TX  78249
Applicant Contact MARK Q NIEDERAUER
Correspondent
Osteobiologics, Inc.
University Business Park
12500 Network, Suite 112
San Antonio,  TX  78249
Correspondent Contact MARK Q NIEDERAUER
Regulation Number888.1100
Classification Product Code
NGR  
Date Received10/16/2001
Decision Date 01/11/2002
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
-
-