510(k) clearances

RESPONSE™ Rib and Pelvic System

OrthoPediatrics Corp. · Orthopedic

K233105Substantially EquivalentTraditionalMDI
Open FDA's page for this record
Third party flag
N
City
Warsaw
Advisory committee description
Orthopedic
Address 1
2850 Frontier Dr.
Statement or summary
Summary
Product code
MDI
Zip code
46582
Applicant
OrthoPediatrics Corp.
Decision date
2024-01-20
Decision code
SESE
Country code
US
Device name
RESPONSE™ Rib and Pelvic System
Advisory committee
OR
Contact
Yan Li
K number
K233105
State
IN
Date received
2023-09-27
Review advisory committee
OR
Postal code
46582
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Rib Replacement
Medical specialty description
Orthopedic
Regulation number
888.3070
Device class
2
Registration number
3015212339, 3008868758, 3009417901, 3006460162, 3008812560
FEI number
3015212339, 3008868758, 3009417901, 3006460162, 3008812560
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.