FDA 510(k) Application Details - K182943

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K182943
Device Name	Staple, Fixation, Bone
Applicant	Nvision Biomedical Technologies, LLC 4754 Shavano Oak, Suite 101 San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Diana Langham Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2018
Decision Date	04/04/2019
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