Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list EBI with 104 510(k) clearances and 13 device recalls. The most recent is a device recall dated Mar 22, 2024: 48" Lead Wires, Replacement Part Number: 1067724-4.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 22, 2024 | 48" Lead Wires, Replacement Part Number: 1067724-4Class II · Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therape | Device recalls |
| Mar 22, 2024 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to Class II · Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therape | Device recalls |
| Mar 22, 2024 | 20" Lead Wires, Replacement Part Number: 1067724-2Class II · Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therape | Device recalls |
| Mar 22, 2024 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to traClass II · Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therape | Device recalls |
| Jan 22, 2020 | Internal Hex Implant SystemK190837 · DZE | 510(k) clearances |
| Aug 31, 2017 | Internal Octa Implant SystemK170031 · DZE | 510(k) clearances |
| Mar 27, 2015 | EBI External Implant SystemK142426 · DZE | 510(k) clearances |
| Dec 15, 2014 | NEXTGEN ALTIUS OCT SYSTEMK140734 · KWP | 510(k) clearances |
| Apr 24, 2014 | POLARIS SPINAL SYSTEM -TRANSLATION SCREWK140123 · NKB | 510(k) clearances |
| Apr 26, 2012 | SOLITAIRE-C CERVICAL SPACER SYSTEMK113796 · OVE | 510(k) clearances |
| Aug 3, 2011 | CONSTRUX EXTERNAL FIXATION DEVICEK111376 · KTT | 510(k) clearances |
| Jun 23, 2010 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100438 · NKB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
