Biomet Spine (Aka Ebi, LLC)

FDA Regulatory Profile

Biomet Spine (Aka Ebi, LLC) appears in FDA public data with 0 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 5, 2014.

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133518MAXAN ANTERIOR CERVICAL PLATE SYSTEMNovember 5, 2014
K140710BIOMET GRAFT DELIVERY SYRINGESSeptember 4, 2014
K132373BIOMET ACCESS SYSTEMMarch 27, 2014
K133746POLARIS SPINAL SYSTEMMarch 12, 2014
K131615POLARIS SPINAL SYSTEMSeptember 4, 2013
K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMFebruary 25, 2013
K123451POLARIS SPINAL SYSTEM - BALLISTA II RODSDecember 3, 2012
K122989BIOMET LATERAL SPACER SYSTEMOctober 24, 2012
K122378NEXTGEN ALTIUS OCT SYSTEMSeptember 20, 2012
K113593NEXTGEN ALTIUS OCT SYSTEMApril 17, 2012
K110650ZYSTON ARC INTERBODY SPACERJune 30, 2011
K100805GALLERY LAMINOPLASTY FIXATION SYSTEMJuly 20, 2010
K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEMJune 23, 2010