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FDA 510(k) Application Details - K200701
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K200701
Device Name
Plate, Fixation, Bone
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Drive, Suite 400
Miami, FL 33156 US
Other 510(k) Applications for this Company
Contact
Diana Taylor
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
03/18/2020
Decision Date
05/14/2020
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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