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FDA 510(k) Application Details - K232387
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K232387
Device Name
Staple, Fixation, Bone
Applicant
Treace Medical Concepts
100 Palmetto Park Place
Ponte Vedra, FL 32081 US
Other 510(k) Applications for this Company
Contact
Brittany Grochala
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/09/2023
Decision Date
08/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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