Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120794
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K120794
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
TORNIER, INC.
7701 FRANCE AVE SOUTH
SUITE 600
EDINA, MN 55435 US
Other 510(k) Applications for this Company
Contact
BRAHIM HADRI
Other 510(k) Applications for this Contact
Regulation Number
888.3660
More FDA Info for this Regulation Number
Classification Product Code
KWS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/15/2012
Decision Date
04/13/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact