FDA 510(k) Application Details - K250346

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K250346
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Elute Inc. 417 Wakara Way, Suite 3510 Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Ashok Khandkar Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2025
Decision Date	02/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review