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FDA 510(k) Application Details - K230761
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K230761
Device Name
Nail, Fixation, Bone
Applicant
Smith & Nephew Inc.
1450 Brooks Rd E
Memphis, TN 38116 US
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Contact
Hiral Rathod
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
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More FDA Info for this Product Code
Date Received
03/20/2023
Decision Date
06/14/2023
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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