FDA 510(k) Application Details - K241906

Device Classification Name	More FDA Info for this Device
510(K) Number	K241906
Device Name	BioBrace« Reinforced Implant
Applicant	CONMED Corporation 525 French Rd Utica, NY 13502 US Other 510(k) Applications for this Company
Contact	Mirela Gjini Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	07/29/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review