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510(k) K233105

Device
RESPONSE? Rib and Pelvic System
Applicant
OrthoPediatrics Corp.
510(k) number
K233105
Product code
MDI
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-20
Date received
2023-09-27
Regulation
888.3070
Classification name
Prosthesis, Rib Replacement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yan Li
Address
2850 Frontier Dr. Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MDI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.2014-11-18