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, Lumbar
510(k) Number K180687
Device Name Reliance Lumber IBF System
Applicant
Reliance Medical Systems
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Applicant Contact Bret M Berry
Correspondent
Reliance Medical Systems
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Bret M Berry
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/15/2018
Decision Date 05/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-