FDA 510(k) Application Details - K250997

Device Classification Name	More FDA Info for this Device
510(K) Number	K250997
Device Name	IntegrityÖ Implant
Applicant	Anika Therapeutics, Inc. 32 Wiggins Ave Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Shajunath Nirupama Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2025
Decision Date	06/17/2025
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