FDA 510(k), K160907, DePuy Actis DuoFix Hip Prosthesis

510(K) Number: K160907
Device Name: DePuy Actis DuoFix Hip Prosthesis
Manufacturer: Jaime Weeks
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: MEH
Classification Product Code: KXA
Date Received: 04/01/2016
Decision Date: 07/19/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

Total number of pages: 480
Count of fully redacted pages: 306
Content pages: 174 (480 total - 306 fully redacted)