• 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 methyl methacrylate for cranioplasty
510(k) Number K060763
Device Name STRYKER INJECTABLE CEMENT
Applicant
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Applicant Contact WADE T RUTKOSKIE
Correspondent
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Correspondent Contact WADE T RUTKOSKIE
Regulation Number882.5300
Classification Product Code
GXP  
Date Received03/21/2006
Decision Date 09/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-