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FDA 510(k) Application Details - K201393
Device Classification Name
Prosthesis, Toe, Hemi-, Phalangeal
More FDA Info for this Device
510(K) Number
K201393
Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Applicant
Restor3d, Inc.
311 W Corporation St
Durham, NC 27701 US
Other 510(k) Applications for this Company
Contact
Nathan Evans
Other 510(k) Applications for this Contact
Regulation Number
888.3730
More FDA Info for this Regulation Number
Classification Product Code
KWD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2020
Decision Date
05/25/2022
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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