FDA 510(k) Application Details - K240846

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K240846
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	CarboFix Orthopedics Ltd. 11 Ha'Hoshlim Street Herzeliya 4672411 IL Other 510(k) Applications for this Company
Contact	Hila Wachsler-Avrahami Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2024
Decision Date	04/25/2024
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