FDA 510(k) Application Details - K983710

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

  More FDA Info for this Device
510(K) Number K983710
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact FRED MCCLURE
Other 510(k) Applications for this Contact
Regulation Number 888.3350

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

  More FDA Info for this Product Code
Date Received 10/21/1998
Decision Date 12/02/1998
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