Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221542
Device Classification Name
More FDA Info for this Device
510(K) Number
K221542
Device Name
Galileo Vertebral Body Replacement Device
Applicant
Bright Spine
834 NE 33rd Street
Boca Raton, FL 33431 US
Other 510(k) Applications for this Company
Contact
Robert Simonson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2022
Decision Date
01/13/2023
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact