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FDA 510(k) Application Details - K142569
Device Classification Name
Prosthesis, Wrist, Hemi-, Ulnar
More FDA Info for this Device
510(K) Number
K142569
Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Applicant
APTIS MEDICAL, LLC.
3602 GLENVIEW AVE.
GLENVIEW, KY 40025 US
Other 510(k) Applications for this Company
Contact
Bryann Babb
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
09/12/2014
Decision Date
04/03/2015
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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