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FDA 510(k) Application Details - K982268
Device Classification Name
Prosthesis, Wrist, Hemi-, Ulnar
More FDA Info for this Device
510(K) Number
K982268
Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Applicant
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
LOUISE M FOCHT
Other 510(k) Applications for this Contact
Regulation Number
888.3810
More FDA Info for this Regulation Number
Classification Product Code
KXE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/29/1998
Decision Date
12/04/1998
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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