FDA 510(k) Application Details - K192013

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K192013
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-Echterdingen 70771 DE Other 510(k) Applications for this Company
Contact	Melanie Lubjuhn Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2019
Decision Date	04/07/2020
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