FDA 510(k) Application Details - K241262

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K241262
Device Name	Plate, Fixation, Bone
Applicant	Paragon 28, Inc. 14445 Grasslands Dr Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Edward Wells-Spicer Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2024
Decision Date	06/05/2024
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