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FDA 510(k) Application Details - K965204
Device Classification Name
Prosthesis, Wrist, Carpal Trapezium
More FDA Info for this Device
510(K) Number
K965204
Device Name
Prosthesis, Wrist, Carpal Trapezium
Applicant
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO, CA 92121 US
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Contact
LOUISE M FOCHT
Other 510(k) Applications for this Contact
Regulation Number
888.3770
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Classification Product Code
KYI
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More FDA Info for this Product Code
Date Received
12/26/1996
Decision Date
06/03/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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