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FDA 510(k) Application Details - K122692
Device Classification Name
More FDA Info for this Device
510(K) Number
K122692
Device Name
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
Contact
ANTHONY FRANCALANCIA
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2012
Decision Date
12/03/2012
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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