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FDA 510(k) Application Details - K182307
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K182307
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Paragon 28, Inc
4B Inverness Ct. E, Ste 280
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Eric Lintula
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
08/24/2018
Decision Date
01/14/2019
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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