Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K231483
Device Classification Name
More FDA Info for this Device
510(K) Number
K231483
Device Name
MySpine Unilateral Guides
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro 6874 CH
Other 510(k) Applications for this Company
Contact
Stefano Baj
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2023
Decision Date
07/21/2023
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