Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K232941
Device Name Megaloop Button System
Applicant
Suzhou Endophix Co., Ltd.
# 151, Fengli Rd., Sip
Suzhou,  CN 215000
Applicant Contact Juan Wu
Correspondent
Suzhou Endophix Co., Ltd.
# 151, Fengli Rd., Sip
Suzhou,  CN 215000
Correspondent Contact Juan Wu
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HTN  
Date Received09/20/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-