ClearanceBrief
Company ยท US

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2014. Name variants (Inc, Corp, punctuation) are merged.

13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
NKBThoracolumbosacral Pedicle Screw System4
KWPAppliance, Fixation, Spinal Interlaminal2
MAXIntervertebral Fusion Device With Bone Graft, Lumbar2
FMFSyringe, Piston1
KWQAppliance, Fixation, Spinal Intervertebral Body1
NQWOrthosis, Spine, Plate, Laminoplasty, Metal1
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis1
PDQNeurosurgical Nerve Locator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 5, 2014K133518MAXAN ANTERIOR CERVICAL PLATE SYSTEM
Biomet Spine (Aka Ebi, LLC)
KWQ
Sep 4, 2014K140710BIOMET GRAFT DELIVERY SYRINGES
Biomet Spine (Aka Ebi, LLC)
FMF
Mar 27, 2014K132373BIOMET ACCESS SYSTEM
Biomet Spine (Aka Ebi, LLC)
PDQ
Mar 12, 2014K133746POLARIS SPINAL SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB
Sep 4, 2013K131615POLARIS SPINAL SYSTEM
Biomet Spine (Aka Ebi, LLC)
OSH
Feb 25, 2013K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB
Dec 3, 2012K123451POLARIS SPINAL SYSTEM - BALLISTA II RODS
Biomet Spine (Aka Ebi, LLC)
NKB
Oct 24, 2012K122989BIOMET LATERAL SPACER SYSTEM
Biomet Spine (Aka Ebi, LLC)
MAX
Sep 20, 2012K122378NEXTGEN ALTIUS OCT SYSTEM
Biomet Spine (Aka Ebi, LLC)
KWP
Apr 17, 2012K113593NEXTGEN ALTIUS OCT SYSTEM
Biomet Spine (Aka Ebi, LLC)
KWP
Jun 30, 2011K110650ZYSTON ARC INTERBODY SPACER
Biomet Spine (Aka Ebi, LLC)
MAX
Jul 20, 2010K100805GALLERY LAMINOPLASTY FIXATION SYSTEM
Biomet Spine (Aka Ebi, LLC)
NQW
Jun 23, 2010K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB

Latest recalls

DateFirm and productCodeLinked 510(k)
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