FDA 510(k) Application Details - K150394

Device Classification Name	More FDA Info for this Device
510(K) Number	K150394
Device Name	Tyber Medical Wedge System
Applicant	TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 MORRISTOWN, NJ 07960 US Other 510(k) Applications for this Company
Contact	JEFF TYBER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2015
Decision Date	07/28/2015
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