Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132704
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K132704
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
BIOMET
56 EAST BELL DR.
P.O BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
SUZANA OTANO
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
LXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/29/2013
Decision Date
10/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact