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 K060408
Device Name NORIAN SRS BONE VOID FILLER
Applicant
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact ANGELA J SILVESTRI
Correspondent
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/16/2006
Decision Date 03/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-