FDA 510(k) Application Details - K231134

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K231134
Device Name	Spinal Vertebral Body Replacement Device
Applicant	Signature Orthopaedics Pty Ltd 7 Sirius Road Lane Cove West 2066 AU Other 510(k) Applications for this Company
Contact	Declan Brazil Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2023
Decision Date	02/13/2024
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