Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130051
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K130051
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT CEDEX 38334 FR
Other 510(k) Applications for this Company
Contact
DAMIEN GUILLAUD
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/2013
Decision Date
07/15/2013
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