FDA 510(k) Application Details - K182352

Device Classification Name	More FDA Info for this Device
510(K) Number	K182352
Device Name	SP-LINKÖ System
Applicant	Medical Designs LLC 6709 S. Minnesota Ave, Suite 204 Sioux Falls, SD 57108 US Other 510(k) Applications for this Company
Contact	Kristi Vondra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2018
Decision Date	11/21/2018
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