FDA 510(k) Application Details - K250395

Device Classification Name	More FDA Info for this Device
510(K) Number	K250395
Device Name	BioBrace « RC Delivery System
Applicant	CONMED Corporation 525 French Road Utica, NY 13502 US Other 510(k) Applications for this Company
Contact	Dionne Sanders Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2025
Decision Date	04/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review