FDA 510(k) Application Details - DEN200035

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200035
Device Name	BEAR (Bridge-Enhanced ACL Repair) Implant
Applicant	Miach Orthopaedics, Inc. 69 Milk Street Suite 100 Westborough, MA 01581 US Other 510(k) Applications for this Company
Contact	Martha Shadan 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	06/04/2020
Decision Date	12/16/2020
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review