FDA 510(k) Application Details - K192989

Device Classification Name	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented   More FDA Info for this Device
510(K) Number	K192989
Device Name	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Applicant	Maxx Orthopedics, Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 US Other 510(k) Applications for this Company
Contact	Priscilla Herpai Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	OQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2019
Decision Date	10/29/2020
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