Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210573
Device Classification Name
More FDA Info for this Device
510(K) Number
K210573
Device Name
Velofix SA Cervical Cage
Applicant
U&I Corporation
20, Sandan-ro 76beon-gil(Rd)
Uijeongbu-si 11781 KR
Other 510(k) Applications for this Company
Contact
Jee-Ae Bang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2021
Decision Date
11/19/2021
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact