FDA 510(k) Application Details - K213272

Device Classification Name	More FDA Info for this Device
510(K) Number	K213272
Device Name	Formus Hip
Applicant	Formus Labs, Ltd Level 9 Bioengineering House 70 Symonds St., Grafton Auckland 1010 NZ Other 510(k) Applications for this Company
Contact	Richie Christian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	03/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review