FDA 510(k) Application Details - K150730

Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

  More FDA Info for this Device
510(K) Number K150730
Device Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant ZIMMER
75, QUEEN STREET, SUITE 3300
MONTREAL H3C 2N6 CA
Other 510(k) Applications for this Company
Contact CHRISTOPHER MCLEAN
Other 510(k) Applications for this Contact
Regulation Number 888.3650

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

  More FDA Info for this Product Code
Date Received 03/20/2015
Decision Date 06/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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