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FDA 510(k) Application Details - K201227
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K201227
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood, CO 80112 US
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Contact
Haylie Hertz
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2020
Decision Date
07/17/2020
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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