Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 


New Search Back To Search Results

510(k) Premarket Notification Database

Device Classification Name plate, fixation, bone
510(k) NumberK071577
Device NameBIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
Applicant
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville,  FL  32218
Contactkim reed
Regulation Number888.3030
Classification Product Code
HRS
Date Received06/08/2007
Decision Date 09/06/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH