FDA 510(k) Application Details - K202151

Device Classification Name	More FDA Info for this Device
510(K) Number	K202151
Device Name	Smart SPACE Shoulder System
Applicant	TechMah Medical LLC 2099 Thunderhead Rd. Suite 302 Knoxville, TN 37922 US Other 510(k) Applications for this Company
Contact	Mohamed R. Mahfouz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2020
Decision Date	02/03/2021
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