FDA 510(k) Application Details - K122773

Device Classification Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented   More FDA Info for this Device
510(K) Number	K122773
Device Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant	STELKAST COMPANY 200 HIDDEN VALLEY RD. MCMURRAY, PA 15317 US Other 510(k) Applications for this Company
Contact	DAVID STUMPO 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	09/10/2012
Decision Date	10/09/2012
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