FDA 510(k) Application Details - K191047

Device Classification Name	More FDA Info for this Device
510(K) Number	K191047
Device Name	ADI TiDAL Osteotomy Wedge
Applicant	Additive Device, Inc. (ADI) d/b/a restor3d 311 W Corporation St. Durham, NC 27701 US Other 510(k) Applications for this Company
Contact	Nathan Evans Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2019
Decision Date	11/05/2019
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