Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220452
Device Classification Name
More FDA Info for this Device
510(K) Number
K220452
Device Name
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Applicant
Materialise NV
Technologielaan 15
Leuven 3001 BE
Other 510(k) Applications for this Company
Contact
Jenny Jones
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QHE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/2022
Decision Date
08/17/2022
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