Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181898
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K181898
Device Name
Screw, Fixation, Bone
Applicant
Trilliant Surgical
727 N Shepherd Dr. STE 100
Houston, TX 77007 US
Other 510(k) Applications for this Company
Contact
Jon Olson
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2018
Decision Date
10/26/2018
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