FDA 510(k) Applications Submitted by BIOMET SPINE (AKA EBI, LLC)
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140710 |
03/21/2014 |
BIOMET GRAFT DELIVERY SYRINGES |
BIOMET SPINE (AKA EBI, LLC) |
| K133518 |
11/15/2013 |
MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K110650 |
03/04/2011 |
ZYSTON ARC INTERBODY SPACER |
BIOMET SPINE (AKA EBI, LLC) |
| K122989 |
09/26/2012 |
BIOMET LATERAL SPACER SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K100805 |
03/22/2010 |
GALLERY LAMINOPLASTY FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K131615 |
06/03/2013 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K122378 |
08/06/2012 |
NEXTGEN ALTIUS OCT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K113593 |
12/05/2011 |
NEXTGEN ALTIUS OCT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K100409 |
02/16/2010 |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K123451 |
11/09/2012 |
POLARIS SPINAL SYSTEM - BALLISTA II RODS |
BIOMET SPINE (AKA EBI, LLC) |
| K132373 |
07/30/2013 |
BIOMET ACCESS SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K123549 |
11/19/2012 |
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
| K133746 |
12/09/2013 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
|
|
