FDA.report

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

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF

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Other 510(k) Records For Product Code MDI

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