FDA.reportPublic FDA data

510(k) K232941

Device
Megaloop Button System
Applicant
Suzhou Endophix Co., Ltd.
510(k) number
K232941
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-03
Date received
2023-09-20
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Juan Wu
Address
# 151, Fengli Rd., Sip Suzhou CN 215000 215000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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