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FDA 510(k) Application Details - K222645
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K222645
Device Name
Staple, Fixation, Bone
Applicant
Treace Medical Concepts
203 Fort Wade Road, Suite 150
Ponte Vedra, FL 32081 US
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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
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More FDA Info for this Product Code
Date Received
09/01/2022
Decision Date
11/21/2022
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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