FDA 510(k) Application Details - K200718

Device Classification Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained   More FDA Info for this Device
510(K) Number	K200718
Device Name	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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	888.3800   More FDA Info for this Regulation Number
Classification Product Code	JWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2020
Decision Date	10/15/2020
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