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FDA 510(k) Application Details - K213489
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K213489
Device Name
Plate, Fixation, Bone
Applicant
WishBone Medical, Inc.
100 Capital Drive
Warsaw, IN 46582 US
Other 510(k) Applications for this Company
Contact
Ramakrishna Bajaj
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
11/01/2021
Decision Date
01/27/2022
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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