FDA 510(k) Application Details - K233721

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K233721
Device Name	Screw, Fixation, Intraosseous
Applicant	KLS-Martin L.P. 11201 Saint Johns Industrial Parkway South Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Melissa Bachorski Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2023
Decision Date	09/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review