Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210035
Device Classification Name
More FDA Info for this Device
510(K) Number
K210035
Device Name
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Applicant
Aegis Spine
9781 S. Meridian Blvd, Ste 300
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Kay Kwon
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2021
Decision Date
02/16/2021
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact