FDA 510(k) Application Details - K250304

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K250304
Device Name	Screw, Fixation, Bone
Applicant	Vilex LLC 111 Moffitt Street McMinnville, TN 37110 US Other 510(k) Applications for this Company
Contact	Scott Armacost 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	02/03/2025
Decision Date	03/05/2025
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