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FDA 510(k) Application Details - K172189
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K172189
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Truemed Group LLC
2002 Timberloch Place Suite 200
The Woodlands, TX 77380 US
Other 510(k) Applications for this Company
Contact
Nina Galeana Rodriguez
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
07/20/2017
Decision Date
01/16/2018
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
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