Ebi, Llc

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
8
Inspections
4
Compliance Actions
0

Known Names

ebi, e-bi

Recent Recalls

NumberClassProductDate
Z-1616-2024Class IIBiomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an estMarch 22, 2024
Z-1617-2024Class IIBiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an establMarch 22, 2024
Z-1619-2024Class II48" Lead Wires, Replacement Part Number: 1067724-4March 22, 2024
Z-1618-2024Class II20" Lead Wires, Replacement Part Number: 1067724-2March 22, 2024
Z-0874-2015Class IISolitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded DrilNovember 11, 2014
Z-0909-2015Class IICypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws.October 8, 2014
Z-1811-2014Class IIBiomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw FixaMay 15, 2014
Z-0411-2014Class IIShortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, ParsiSeptember 24, 2013
Z-0359-2014Class IIBIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-SterileAugust 22, 2013
Z-2214-2013Class IICypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cerAugust 13, 2013
Z-2292-2013Class IISolitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusioApril 9, 2013
Z-0954-2013Class IIBiomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris SpinaFebruary 7, 2013
Z-0536-2013Class IIBiomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178September 29, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K190837Internal Hex Implant SystemJanuary 22, 2020
K170031Internal Octa Implant SystemAugust 31, 2017
K142426EBI External Implant SystemMarch 27, 2015
K140734NEXTGEN ALTIUS OCT SYSTEMDecember 15, 2014
K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREWApril 24, 2014
K113796SOLITAIRE-C CERVICAL SPACER SYSTEMApril 26, 2012
K111376CONSTRUX EXTERNAL FIXATION DEVICEAugust 3, 2011
K073116EBI INTERNAL IMPLANT SYSTEMFebruary 28, 2008