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 K023862
Device Name NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact VIKKI M HOFFMAN
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact VIKKI M HOFFMAN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/20/2002
Decision Date 12/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-