510(k) Report

FDA applicant

Ebi Electro Biology

Parsippany, NJ3 decisions1997–19990 recalls

FDA records 3 decisions for Ebi Electro Biology (Parsippany, NJ) from 1997 to 1999: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Ebi Electro Biology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ebi Electro Biology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ebi Electro Biology by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ebi Electro Biology’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973683Omega 21 SystemEbi Electro Biology · 19975cite it
  • K991721Ebi Omega 21 SystemEbi Electro Biology · 19994cite it
  • K973923Ebi Spinelink Anterior Cervical Spinal SystemEbi Electro Biology · 19981cites it

What has FDA decided for it lately?

  • K991721Ebi Omega 21 SystemEbi Electro Biology · 1999
  • K973923Ebi Spinelink Anterior Cervical Spinal SystemEbi Electro Biology · 1998
  • K973683Omega 21 SystemEbi Electro Biology · 1997

All 3 as Ebi Electro Biology →