FDA 510(k) Application Details - K001706

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

  More FDA Info for this Device
510(K) Number K001706
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact LYNNE WITKOWSKI
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 06/05/2000
Decision Date 08/16/2000
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