FDA 510(k) Application Details - K062116

Device Classification Name

  More FDA Info for this Device
510(K) Number K062116
Device Name DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
Contact RHONDA MYER
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 07/25/2006
Decision Date 08/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
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