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 appliance, fixation, spinal intervertebral body
510(k) Number K152282
Device Name Cam Lock Plating System
Applicant
LIFE SPINE, INC
13951 S. Quality Drive
Huntley,  IL  60142
Applicant Contact RANDY LEWIS
Correspondent
LIFE SPINE, INC
13951 S. Quality Drive
Huntley,  IL  60142
Correspondent Contact RANDY LEWIS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/12/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-