FDA 510(k) Application Details - K960906

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

  More FDA Info for this Device
510(K) Number K960906
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant ENCORE ORTHOPEDICS, INC.
8900 SHOAL CREEK BLVD.,
BLDG. 300
AUSTIN, TX 78757 US
Other 510(k) Applications for this Company
Contact ASHELY M BOCK
Other 510(k) Applications for this Contact
Regulation Number 888.3660

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

  More FDA Info for this Product Code
Date Received 03/05/1996
Decision Date 04/15/1996
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