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FDA 510(k) Application Details - K172205
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K172205
Device Name
Staple, Fixation, Bone
Applicant
ExoToe LLC
Po Box 548
Grimes, IA 50111 US
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Contact
Avi Roop
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
07/21/2017
Decision Date
01/11/2018
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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