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FDA 510(k) Application Details - K994393
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K994393
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
TORNIER
200 GREGORY LN.
SUITE C-100
PLEASANT HILL, CA 94523-3389 US
Other 510(k) Applications for this Company
Contact
DAVID W SCHLERF
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
12/28/1999
Decision Date
06/22/2000
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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