Medical Device Manufacturer · US , Parsippany , NJ

Biomet Spine (Aka Ebi, LLC) - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2010
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Spine (Aka Ebi, LLC) Orthopedic ✕
11 devices
1-11 of 11
Cleared Nov 05, 2014
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K133518 · KWQ
Orthopedic · 355d
Cleared Mar 12, 2014
POLARIS SPINAL SYSTEM
K133746 · NKB
Orthopedic · 93d
Cleared Sep 04, 2013
POLARIS SPINAL SYSTEM
K131615 · OSH
Orthopedic · 93d
Cleared Feb 25, 2013
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
K123549 · NKB
Orthopedic · 98d
Cleared Dec 03, 2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
K123451 · NKB
Orthopedic · 24d
Cleared Oct 24, 2012
BIOMET LATERAL SPACER SYSTEM
K122989 · MAX
Orthopedic · 28d
Cleared Sep 20, 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378 · KWP
Orthopedic · 45d
Cleared Apr 17, 2012
NEXTGEN ALTIUS OCT SYSTEM
K113593 · KWP
Orthopedic · 134d
Cleared Jun 30, 2011
ZYSTON ARC INTERBODY SPACER
K110650 · MAX
Orthopedic · 118d
Cleared Jul 20, 2010
GALLERY LAMINOPLASTY FIXATION SYSTEM
K100805 · NQW
Orthopedic · 120d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
K100409 · NKB
Orthopedic · 127d
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