FDA 510(k) Application Details - K250613

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K250613
Device Name	Screw, Fixation, Bone
Applicant	Nvision Biomedical Technologies Inc 4590 Lockhill Selma Rd San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Erin Lansdale 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	02/28/2025
Decision Date	04/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review