FDA 510(k) Application Details - K231453

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K231453
Device Name	Screw, Fixation, Bone
Applicant	Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Diana Langham Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2023
Decision Date	02/16/2024
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