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FDA 510(k) Application Details - K221465
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K221465
Device Name
Plate, Fixation, Bone
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
888.3030
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
05/19/2022
Decision Date
06/17/2022
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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