FDA 510(k) Application Details - K102565

Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

  More FDA Info for this Device
510(K) Number K102565
Device Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact GREGORY NEAL
Other 510(k) Applications for this Contact
Regulation Number 888.3330

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

  More FDA Info for this Product Code
Date Received 09/07/2010
Decision Date 12/22/2010
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