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