FDA 510(k) Application Details - K132104

Device Classification Name Intraoperative Orthopedic Joint Assessment Aid

  More FDA Info for this Device
510(K) Number K132104
Device Name Intraoperative Orthopedic Joint Assessment Aid
Applicant Kamm & Associates
8870 RAVELLO CT
NAPLES, FL 34114 US
Other 510(k) Applications for this Company
Contact DANIEL KAMM, P.E.
Other 510(k) Applications for this Contact
Regulation Number 882.4560

  More FDA Info for this Regulation Number
Classification Product Code ONN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/08/2013
Decision Date 03/21/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact