FDA 510(k) Application Details - K241043

Device Classification Name	More FDA Info for this Device
510(K) Number	K241043
Device Name	Augment Off-Axis Instrument System
Applicant	Fix Surgical 425 Fayette St., #617 Conshohocken, PA 19428 US Other 510(k) Applications for this Company
Contact	Brian Karpinski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2024
Decision Date	05/15/2024
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