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FDA 510(k) Application Details - K210658
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K210658
Device Name
Plate, Fixation, Bone
Applicant
Ortho Solutions UK Ltd
West Station Business Park, Spital Road
Maldon CMF 6FF GB
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Contact
Andy Leither
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
03/04/2021
Decision Date
04/13/2021
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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