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FDA 510(k) Application Details - K213126
Device Classification Name
Device, Fixation, Proximal Femoral, Implant
More FDA Info for this Device
510(K) Number
K213126
Device Name
Device, Fixation, Proximal Femoral, Implant
Applicant
Smith & Nephew Inc.
1450 E Brooks Rd
Memphis, TN 38116 US
Other 510(k) Applications for this Company
Contact
Thomas Fearnley
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2021
Decision Date
09/29/2022
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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