FDA.reportPublic FDA data

510(k) K241983

Device
Fassier-Duval Telescoping IM System
Applicant
Orthopediatrics Canada Ulc Dba Pega Medical
510(k) number
K241983
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-21
Date received
2024-07-08
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Enrique Garcia
Address
1111 Autoroute Chomedey Laval CA H7W 5J8 H7W 5J8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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