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FDA 510(k) Application Details - K200961
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K200961
Device Name
Plate, Fixation, Bone
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 US
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2020
Decision Date
05/08/2020
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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