FDA 510(k), K160907, DePuy Actis DuoFix Hip Prosthesis
FDA 510(k), K160907, DePuy Actis DuoFix Hip Prosthesis
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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: 04/01/2016
Date Received: 07/19/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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: 04/01/2016
Date Received: 07/19/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic