Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171211
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K171211
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Orthopaedic Implant Company
770 Smithridge Dr. #400
Reno, NV 89502 US
Other 510(k) Applications for this Company
Contact
Douglas Fulton
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2017
Decision Date
09/27/2017
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