Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K211785
Device Classification Name
More FDA Info for this Device
510(K) Number
K211785
Device Name
CASSATTÖ SIJ Fixation System
Applicant
CTL Medical Corporation
4550 Excel Parkway
Addison, TX 75001 US
Other 510(k) Applications for this Company
Contact
Sean Suh
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
06/09/2021
Decision Date
10/17/2022
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