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FDA 510(k) Application Details - K211322
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K211322
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
04/30/2021
Decision Date
08/30/2021
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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