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FDA 510(k) Application Details - K182148
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K182148
Device Name
Screw, Fixation, Bone
Applicant
Paragon 28, Inc.
4B Inverness Ct. E, STE 280
Engelwood, 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
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2018
Decision Date
09/07/2018
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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