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FDA 510(k) Application Details - K210869
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K210869
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Haylie Hertz
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2021
Decision Date
06/28/2021
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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