FDA 510(k) Application Details - K141972

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

  More FDA Info for this Device
510(K) Number K141972
Device Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant TOTAL JOINT ORTHOPEDICS, INC.
1567 E. Stratford Avenue
Salt Lake City, UT 84106 US
Other 510(k) Applications for this Company
Contact CHRIS WEABER
Other 510(k) Applications for this Contact
Regulation Number 888.3358

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

  More FDA Info for this Product Code
Date Received 07/21/2014
Decision Date 10/09/2014
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