• 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 equipment, traction, powered
510(k) Number K103248
Device Name INTEGRITY SPINAL CARE SYSTEM
Applicant
INTEGRA LIFE SCIENCES
5795 SOUTH SANDHILL ROAD
SUITE F,
las vegas,  NV  89120
Applicant Contact james j gibson
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
newton,  CT  06470
Regulation Number890.5900
Classification Product Code
ITH  
Date Received11/03/2010
Decision Date 04/05/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-