FDA 510(k) Application Details - K181794

Device Classification Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K181794
Device Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Applicant	Exactech, Inc. 2320 NW 66th CT Gainesville, FL 32653 US Other 510(k) Applications for this Company
Contact	Patrick Hughes Other 510(k) Applications for this Contact
Regulation Number	888.3565   More FDA Info for this Regulation Number
Classification Product Code	MBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2018
Decision Date	09/28/2018
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