Medical Device Manufacturer · US , Parsippany , NJ

Ebi, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2011
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ebi, LLC Orthopedic ✕

4 devices
1-4 of 4
Cleared Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734 · KWP
Orthopedic · 266d
Cleared Apr 24, 2014
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
K140123 · NKB
Orthopedic · 98d
Cleared Apr 26, 2012
SOLITAIRE-C CERVICAL SPACER SYSTEM
K113796 · OVE
Orthopedic · 125d
Cleared Aug 03, 2011
CONSTRUX EXTERNAL FIXATION DEVICE
K111376 · KTT
Orthopedic · 79d
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