FDA 510(k) Application Details - K243578

Device Classification Name	More FDA Info for this Device
510(K) Number	K243578
Device Name	BEAR« (Bridge-Enhanced ACL Restoration) Implant
Applicant	Miach Orthopaedics, Inc. 69 Milk Street Suite 100 Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Rita Paparazzo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2024
Decision Date	03/06/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review