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 Integrated Fixation, Cervical
510(k) Number K081194
Device Name INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
Applicant
Rsb Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
Rsb Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
OVD  
Date Received04/28/2008
Decision Date 05/29/2008
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
-
-