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 Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K212266
Device Name FIX-C PEEK Anterior Cervical Interbody System
Applicant
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-Ho, 55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact Dajung Lee
Correspondent
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-Ho, 55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact Dajung Lee
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/20/2021
Decision Date 12/21/2021
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
-
-