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

Biomet Spine (Aka Ebi, LLC) has 13 FDA 510(k) cleared orthopedic devices. Based in Parsippany, US.

Historical record: 13 cleared submissions from 2010 to 2014.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Biomet Spine (Aka Ebi, LLC)
13 devices
1-12 of 13
Cleared Nov 05, 2014
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K133518 · KWQ
Orthopedic · 355d
Cleared Sep 04, 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · FMF
General Hospital · 167d
Cleared Mar 27, 2014
BIOMET ACCESS SYSTEM
K132373 · PDQ
Neurology · 240d
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
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All13 Orthopedic 11 Neurology 1 General Hospital 1