FDA.report

510(k) K223709

Device
Kyphoplasty Balloon Catheter
Applicant
Jiangsu Changmei Medtech Co., Ltd.
510(k) number
K223709
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-16
Date received
2022-12-12
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yang Lifan
Address
#27, Xinke W. Rd., Luoyang Town Wujin District Changzhou CN 213104 213104

FDA Registration Numbers

Source Documents

510(k) summary PDF

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