FDA 510(k) Application Details - K191981

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal   More FDA Info for this Device
510(K) Number	K191981
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant	OsteoRemedies, LLC 6800 Poplar Avenue, #120 Germantown, TN 38138 US Other 510(k) Applications for this Company
Contact	Eric Stookey Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	KWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2019
Decision Date	08/23/2019
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