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FDA 510(k) Application Details - K023531
Device Classification Name
Prosthesis, Toe, Constrained, Polymer
More FDA Info for this Device
510(K) Number
K023531
Device Name
Prosthesis, Toe, Constrained, 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
888.3720
More FDA Info for this Regulation Number
Classification Product Code
KWH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2002
Decision Date
01/17/2003
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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