Ebi, Llc
Ebi, Llc appears in FDA public data with 13 recalls, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1616-2024, Class II) was initiated on March 22, 2024. Its most recent 510(k) clearance was granted on January 22, 2020.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Known Names
ebi, e-bi
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1616-2024 | Class II | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an est | March 22, 2024 |
| Z-1617-2024 | Class II | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an establ | March 22, 2024 |
| Z-1619-2024 | Class II | 48" Lead Wires, Replacement Part Number: 1067724-4 | March 22, 2024 |
| Z-1618-2024 | Class II | 20" Lead Wires, Replacement Part Number: 1067724-2 | March 22, 2024 |
| Z-0874-2015 | Class II | Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Dril | November 11, 2014 |
| Z-0909-2015 | Class II | Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. | October 8, 2014 |
| Z-1811-2014 | Class II | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixa | May 15, 2014 |
| Z-0411-2014 | Class II | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsi | September 24, 2013 |
| Z-0359-2014 | Class II | BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile | August 22, 2013 |
| Z-2214-2013 | Class II | Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cer | August 13, 2013 |
| Z-2292-2013 | Class II | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusio | April 9, 2013 |
| Z-0954-2013 | Class II | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spina | February 7, 2013 |
| Z-0536-2013 | Class II | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 | September 29, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K190837 | Internal Hex Implant System | January 22, 2020 |
| K170031 | Internal Octa Implant System | August 31, 2017 |
| K142426 | EBI External Implant System | March 27, 2015 |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | December 15, 2014 |
| K140123 | POLARIS SPINAL SYSTEM -TRANSLATION SCREW | April 24, 2014 |
| K113796 | SOLITAIRE-C CERVICAL SPACER SYSTEM | April 26, 2012 |
| K111376 | CONSTRUX EXTERNAL FIXATION DEVICE | August 3, 2011 |
| K073116 | EBI INTERNAL IMPLANT SYSTEM | February 28, 2008 |