FDA 510(k) Application Details - K210420

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K210420
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	Medynus Inc. 18 Technology Dr. Ste 109 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	David Shin 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	02/11/2021
Decision Date	04/19/2021
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