FDA 510(k) Application Details - K141395

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

  More FDA Info for this Device
510(K) Number K141395
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant LIMACORPORATE S.P.A.
VIA NAZIONALE, 52
VILLANOVA DI SAN DANIELE
UDINE 33038 IT
Other 510(k) Applications for this Company
Contact STEPHEN J PEOPLES
Other 510(k) Applications for this Contact
Regulation Number 888.3358

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

  More FDA Info for this Product Code
Date Received 05/28/2014
Decision Date 06/30/2014
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