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FDA 510(k) Application Details - K203832
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K203832
Device Name
Staple, Fixation, Bone
Applicant
Wright Medical
1023 Cherry Road
Memphis, TN 38117 US
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Contact
Jonathan DiMotta
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
12/30/2020
Decision Date
05/07/2021
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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