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 Interlaminal
510(k) Number K070300
Device Name EXPEDIUM SFX CROSS CONNECTOR SYSTEM
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI   NKB  
Date Received01/31/2007
Decision Date 04/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-