510(k) Premarket Notification Database
Device Classification Name |
plate, fixation, bone
|
510(k) Number | K071577 |
Device Name | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER |
Applicant |
BIOMET MICROFIXATION, INC.
|
1520 tradeport dr. |
jacksonville,
FL
32218 |
|
Contact | kim reed |
Regulation Number | 888.3030 |
Classification Product Code |
|
Date Received | 06/08/2007 |
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
|
|
|