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FDA 510(k) Application Details - K192504
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K192504
Device Name
Plate, Fixation, Bone
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 US
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Contact
Rachel Osbeck
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
09/12/2019
Decision Date
10/30/2019
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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