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FDA 510(k) Application Details - K170923
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K170923
Device Name
Staple, Fixation, Bone
Applicant
Paragon 28
4B Inverness Ct. E., STE 280
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Frank S. Bono
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/2017
Decision Date
07/24/2017
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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