FDA 510(k) Application Details - K151741

Device Classification Name

  More FDA Info for this Device
510(K) Number K151741
Device Name HA Minuteman G3 MIS Fusion Plate
Applicant SPINAL SIMPLICITY LLC
10995 QUIVIRA ROAD
OVERLAND PARK, KS 66210 US
Other 510(k) Applications for this Company
Contact JULIE MCKEE
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code PEK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/26/2015
Decision Date 08/20/2015
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