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FDA 510(k) Application Details - K182898
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K182898
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
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
888.3040
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
10/16/2018
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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