FDA 510(k) Application Details - K200045

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate   More FDA Info for this Device
510(K) Number	K200045
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant	implantcast, GmbH Luneburger Schanze 26 21614 DE Other 510(k) Applications for this Company
Contact	Juliane Hoppner 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	01/08/2020
Decision Date	10/16/2020
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