FDA 510(k) Application Details - K020572

Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

  More FDA Info for this Device
510(K) Number K020572
Device Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
Other 510(k) Applications for this Company
Contact NANCY J RIEDER
Other 510(k) Applications for this Contact
Regulation Number 888.3353

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

  More FDA Info for this Product Code
Date Received 02/21/2002
Decision Date 03/04/2002
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