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FDA 510(k) Application Details - K033046
Device Classification Name
Prosthesis, Subtalar, Plug, Polymer
More FDA Info for this Device
510(K) Number
K033046
Device Name
Prosthesis, Subtalar, Plug, Polymer
Applicant
NEXA ORTHOPEDICS, INC.
990 PARK CENTER DR., SUITE H
VISTA, CA 92083 US
Other 510(k) Applications for this Company
Contact
LOUISE M FOCHT
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MJW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2003
Decision Date
12/23/2003
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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