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 Filler, Bone Void, Calcium Compound
510(k) Number K062495
Device Name HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
Applicant
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact MELANIE ARCHER
Correspondent
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact MELANIE ARCHER
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
FMF  
Date Received08/25/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-