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 Washer, Bolt Nut
510(k) Number K232780
Device Name CC-Clip® Implant System
Applicant
Cc-Instruments, Inc.
850 New Burton Rd.
Suite 201
Dover,  DE  19904
Applicant Contact Juha Ranne
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Mason Makulinski
Regulation Number888.3030
Classification Product Code
HTN  
Date Received09/11/2023
Decision Date 12/18/2023
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
-
-