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FDA 510(k) Application Details - K223589
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K223589
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
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
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2022
Decision Date
03/03/2023
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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