FDA.reportPublic FDA data

510(k) K232394

Device
Internal Locking Plate and Screw Fixation System
Applicant
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
510(k) number
K232394
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-15
Date received
2023-08-09
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jing Huang
Address
# 12, Jinfeng Rd., W. Taihu Science And Technology Industrial Park Changzhou CN 213149 213149

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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