FDA 510(k) Application Details - K181280

Device Classification Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K181280
Device Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Applicant	Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 US Other 510(k) Applications for this Company
Contact	Dawn J. Wilson Other 510(k) Applications for this Contact
Regulation Number	888.3540   More FDA Info for this Regulation Number
Classification Product Code	KRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2018
Decision Date	06/14/2018
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